Reported Mar 2, 2016 · Terminated
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial,…
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?
- CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, 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. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with
- CR-Flex GSF or LPS-Flex GSF femoralsProvides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees."
- Lot codes and dates
- Item numbers
00-5752-013-0100-5752-013-0200-5752-013-0500-5752-013-0600-5752-014-0100-5752-014-0200-5752-014-0500-5752-014-0600-5752-015-0100-5752-015-0200-5752-015-0500-5752-015-0600-5752-016-0100-5752-016-0200-5752-016-0500-5752-016-0600-5752-017-0100-5752-017-0200-5752-017-0500-5752-017-0600-5762-013-5100-5762-013-5200-5762-014-5100-5762-014-5200-5762-015-5100-5762-015-5200-5762-016-5100-5762-016-5200-5762-017-5100-5762-017-5200-5962-012-5100-5962-012-5200-5962-013-5100-5962-013-5200-5962-014-5100-5962-014-5200-5962-015-5100-5962-015-5200-5962-016-5100-5962-016-5200-5962-017-5100-5962-017-5200-5962-018-5100-5962-018-52
- Lot numbers
947 of 947 codes
110030021100332811003397110035261100360611003637110036391100366711003972110040371100473911004835110049131100491511005025110051241100518011005183110052861100528711005288110053891100545411005613110056691100575611005843110059171100604911006065110061431100620711006225110062441100641211006591110066501100668811006696110067001100673311006807110068341100702011007021110070871100709911007174110071911100720511007274110073721100738611007388110074111100745711007477110075421100766011007662
- Item numbers
- Amount recalled
- 18482
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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