Reported Mar 2, 2016 · Terminated
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM…
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 Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."
- Lot codes and dates
- Item numbers
00-5410-014-0100-5410-014-0200-5410-015-0100-5410-015-0200-5410-016-0100-5410-016-0200-5410-017-0100-5410-017-0200-5410-018-0100-5410-018-0200-5412-014-0200-5412-015-0100-5412-016-0200-5414-013-0100-5414-014-0100-5414-014-0200-5414-015-0100-5414-015-0200-5414-016-0100-5414-016-0200-5416-013-0100-5416-013-0200-5416-014-0100-5416-014-0200-5416-015-0100-5416-015-0200-5416-016-0100-5416-016-0200-5416-017-0100-5416-017-0200-5750-013-0100-5750-013-0200-5750-013-0500-5750-013-0600-5750-014-0100-5750-014-0200-5750-014-0500-5750-014-0600-5750-015-0100-5750-015-0200-5750-015-0500-5750-015-0600-5750-016-0100-5750-016-0200-5750-016-0500-5750-016-0600-5750-017-0100-5750-017-0200-5750-017-0500-5750-017-06
- Lot numbers
3,177 of 3,177 codes
110014391100269311003150110031601100316111003162110031631100316811003169110031731100317411003175110031761100318511003186110031871100319811003202110032031100321011003215110032191100322911003233110032341100323711003243110032461100324711003254110039771100407311004242110042431100426411004265110042931100430811004329110043661100447411004485110044871100448911004509110045151100451711004518110045281100457011004594110046461100467211004678110046851100468611004749110047571100475811004760
- Item numbers
- Amount recalled
- 61485
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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