Recall archive
91 recalls · page 4 of 4
Reported Dec 16, 2015
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2015
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc., Endoscopy Div.
Matched: Brand · Product · Product details — Sterility of device is compromised due to breach in the packaging
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 16, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2015
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Sterility of device maybe compromised
FDA (openFDA device enforcement)
Reported Jun 17, 2015
R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2014
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The stem taper on this device is undersized; the gauge point is not deep enough.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2014
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2014
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
FDA (openFDA device enforcement)
Reported Aug 27, 2014
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R);…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc. Endoscopy Division
Matched: Brand — Sterility of device is compromised due to breach in sterile barrier
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 28, 2014
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product details — A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product · Product details — Inner spherical radius of the shell is undersized.
FDA (openFDA device enforcement)
Reported Jan 1, 2014
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product details — One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
FDA (openFDA device enforcement)
Reported Dec 11, 2013
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product · Product details — The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc. Endoscopy Division
Matched: Brand — Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
25 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2013
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product · Product details — One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a…
FDA (openFDA device enforcement)
Reported Mar 20, 2013
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product details — 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2012
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
Matched: Brand · Product · Product details — Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
FDA (openFDA device enforcement)
Reported Aug 15, 2012
Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc. Endoscopy Division
Matched: Brand · Product · Product details — Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not…
5 more products in this recall
FDA (openFDA device enforcement)
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