Recall archive
84 recalls · page 4 of 4
Reported Jan 2, 2013
Zimmer Spine Ardis Inserter, Rx, non-sterile
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zimmer, Inc.
Matched: Brand · Product · Product details · Reason for recall — Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis…
FDA (openFDA device enforcement)
Reported Dec 26, 2012
COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 5, 2012
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a…
FDA (openFDA device enforcement)
Reported Nov 28, 2012
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2012
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures…
FDA (openFDA device enforcement)
Reported Nov 14, 2012
Alloclassic SL Shaft
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in…
39 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2012
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 10, 2012
00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2012
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2012
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2012
PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The…
FDA (openFDA device enforcement)
Reported Jul 4, 2012
Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually…
FDA (openFDA device enforcement)
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