Reported Mar 2, 2016 · Terminated
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patients with
- severe knee pain and disability due toRheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only."
- Lot codes and dates
- Item numbers
116 of 116 codes
00-5966-013-0100-5966-013-0200-5966-014-0100-5966-014-0200-5966-015-0100-5966-015-0200-5966-016-0100-5966-016-0200-5966-017-0100-5966-017-0200-5970-011-0100-5970-011-0200-5970-012-0100-5970-012-0200-5970-013-0100-5970-013-0200-5970-013-0300-5970-013-0400-5970-014-0100-5970-014-0200-5970-014-0300-5970-014-0400-5970-015-0100-5970-015-0200-5970-015-0300-5970-015-0400-5970-016-0100-5970-016-0200-5970-017-0100-5970-017-0200-5970-018-0100-5970-018-0200-5972-011-0100-5972-011-0200-5972-012-0100-5972-012-0200-5972-013-0100-5972-013-0200-5972-013-0300-5972-013-0400-5972-014-0100-5972-014-0200-5972-014-0300-5972-014-0400-5972-015-0100-5972-015-0200-5972-015-0300-5972-015-0400-5972-016-0100-5972-016-0200-5972-017-0100-5972-017-0200-5972-018-0100-5972-018-0200-5990-011-0100-5990-011-0200-5990-011-3100-5990-011-3200-5990-012-0100-5990-012-02
- Lot numbers
1,918 of 1,918 codes
110027711100338011003415110034501100345111003469110034771100357411003575110035761100358311003586110035931100359711003601110036021100361211003613110036261100364311003644110036661100367311003825110038321100387011003871110038891100389011003893110039411100394211003954110039561100403511004043110040581100408011004101110041891100430211004500110045081100454311004566110045971100468311004766110048061100481711004868110048691100487011004894110049141100494611004950110049521100495411004955
- Item numbers
- Amount recalled
- 32508
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- FL
Why it was recalled
LDPE bag containing the implant adheres to the highly polished implant surface.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Zimmer Biomet, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.