Reported Mar 2, 2016 · Terminated
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented,…
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 Porous FEM NexGen Knee CR 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
00-5970-011-3100-5970-011-3200-5970-012-3100-5970-012-3200-5970-013-3100-5970-013-3200-5970-013-3300-5970-013-3400-5970-014-3100-5970-014-3200-5970-014-3300-5970-014-3400-5970-015-3100-5970-015-3200-5970-015-3300-5970-015-3400-5970-016-3100-5970-016-3200-5970-017-3100-5970-017-3200-5970-018-3100-5970-018-3200-5972-011-3100-5972-011-3200-5972-012-3100-5972-012-3200-5972-013-3300-5972-013-3400-5972-014-3300-5972-014-3400-5972-015-3300-5972-015-3400-5972-016-3100-5972-016-3200-5972-017-3100-5972-017-3200-5972-018-3100-5972-018-32
- Lot numbers
1,093 of 1,093 codes
110033801100341511003477110035741100358311003586110035971100360111003602110036121100361311003626110036441100366611003673110038321100387011003871110038891100389011003893110039411100394211003954110040351100405811004080110041891100430211004500110045661100459711004683110047661100481711004868110048691100487011004946110049501100495211004954110049571100495811004972110049801100501811005054110050681100509611005100110052321100524811005320110053281100537411005425110054441100546111005491
- Item numbers
- Amount recalled
- 18093
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.
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