Recall archive
59 recalls · page 2 of 3
Reported Nov 30, 2016
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — The peel pouches for the affected reaming rods and extraction hooks are delaminating.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 24, 2016
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Reason for recall — DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and…
FDA (openFDA device enforcement)
Reported Jul 27, 2016
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details · Reason for recall — DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a…
FDA (openFDA device enforcement)
Reported Jul 20, 2016
6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Labeling does not match the cleared indications for use in the United States and Canada.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details · Reason for recall — DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not…
FDA (openFDA device enforcement)
Reported Jun 22, 2016
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct;…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2016
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on…
FDA (openFDA device enforcement)
Reported Apr 27, 2016
Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Reason for recall — DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2016
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2016
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details · Reason for recall — DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP…
FDA (openFDA device enforcement)
Reported Jan 13, 2016
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
FDA (openFDA device enforcement)
Reported Dec 16, 2015
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening…
FDA (openFDA device enforcement)
Reported Dec 2, 2015
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius…
FDA (openFDA device enforcement)
Reported Nov 25, 2015
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details · Reason for recall — Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details · Reason for recall — The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine…
FDA (openFDA device enforcement)
Reported Nov 4, 2015
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2015
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject…
FDA (openFDA device enforcement)
Reported Oct 21, 2015
Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2015
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP…
FDA (openFDA device enforcement)
Reported Sep 30, 2015
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees…
1 more product in this recall
FDA (openFDA device enforcement)
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