Recall archive
9 recalls · page 1 of 1
Reported May 25, 2016
Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand · Product · Product details — A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2016
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand — The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand — As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected…
71 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 13, 2016
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand — A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a…
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand — Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot…
FDA (openFDA device enforcement)
Reported Dec 31, 2014
Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand · Reason for recall — Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor…
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand · Reason for recall — Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific…
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Manufacturing B.V.
Matched: Brand · Product · Product details — Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759;…
FDA (openFDA device enforcement)
Reported Feb 26, 2014
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico.…
43 more products in this recall
FDA (openFDA device enforcement)
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