Recall archive
55 recalls · page 2 of 3
Reported Jun 14, 2017
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety…
FDA (openFDA device enforcement)
Reported Dec 14, 2016
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being…
FDA (openFDA device enforcement)
Reported Nov 30, 2016
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Depuy Orthopaedics Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving…
FDA (openFDA device enforcement)
Reported Feb 17, 2016
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is…
FDA (openFDA device enforcement)
Reported Oct 14, 2015
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to…
FDA (openFDA device enforcement)
Reported Jul 29, 2015
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2015
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2015
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be…
FDA (openFDA device enforcement)
Reported Mar 11, 2015
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement…
FDA (openFDA device enforcement)
Reported Jan 21, 2015
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the…
FDA (openFDA device enforcement)
Reported Jan 14, 2015
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the…
FDA (openFDA device enforcement)
Reported Nov 19, 2014
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and…
FDA (openFDA device enforcement)
Reported Oct 15, 2014
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2014
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2014
GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing…
FDA (openFDA device enforcement)
Reported Mar 19, 2014
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome…
FDA (openFDA device enforcement)
Reported Dec 4, 2013
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2013
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the…
FDA (openFDA device enforcement)
Reported Aug 7, 2013
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.DePuy Orthopaedics, Inc.
Matched: Brand — The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological…
FDA (openFDA device enforcement)
Reported Jun 19, 2013
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the…
FDA (openFDA device enforcement)
Reported May 29, 2013
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Reason for recall — DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box.…
FDA (openFDA device enforcement)
Reported May 22, 2013
DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large…
FDA (openFDA device enforcement)
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