Reported Mar 2, 2016 · Terminated
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various…
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?
- LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" 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
00-5764-013-5100-5764-013-5200-5764-014-5100-5764-014-5200-5764-015-5100-5764-015-5200-5764-016-5100-5764-016-5200-5764-017-5100-5764-017-52
- Lots
3,242 of 3,242 codes
110039371100428711004298110043371100454411004612110047691100479711004818110050621100506611005155110052761100559811005680110057051100574811005900110059311100595911005980110061901100673711006764110068271100684011006882110069221100698611007165110072171100727211007323110076511100784911007988110081861100819711008221110082311100831111400099114001041140011911400120114001221140012511400126114001341140015211400165114001701140018711400203114002151140021811400244114002471140027011400271
- Item numbers
- Amount recalled
- 84396
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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