CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR… — Class II medical device recall Z-0838-2016

Terminated recall by Zimmer Biomet, Inc., reported 2016-03-02, distributed nationwide. LDPE bag containing the implant adheres to the highly polished implant surface.

Recall number	`Z-0838-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Zimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated	2016-01-11
Classified	2016-02-22
Reported by FDA	2016-03-02
Terminated	2017-05-23
Distributed	Nationwide (US)
Countries outside the US	AR, AT, AU, BB, BE, BM, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, ES, FR, GB, GT, HK, HN, HR, IL, IN, IT, JM, JP, KR, MX, MY, NI, NZ, PA, PE, SE, SG, SV, TH, TW, VE
Quantity	61,485
Lot numbers	`11001439`, `11002693`, `11003150`, `11003160`, `11003161`, `11003162`, `11003163`, `11003168`, `11003169`, `11003173`, `11003174`, `11003175`, `11003176`, `11003185`, `11003186`, `11003187`, `11003198`, `11003202`, `11003203`, `11003210`, `11003215`, `11003219`, `11003229`, `11003233`, `11003234`, `11003237`, `11003243`, `11003246`, `11003247`, `11003254`, `11003977`, `11004073`, `11004242`, `11004243`, `11004264`, `11004265`, `11004293`, `11004308`, `11004329`, `11004366` and 460 more
Model numbers	`00-5410-014-01`, `00-5410-014-02`, `00-5410-015-01`, `00-5410-015-02`, `00-5410-016-01`, `00-5410-016-02`, `00-5410-017-01`, `00-5410-017-02`, `00-5410-018-01`, `00-5410-018-02`, `00-5412-014-02`, `00-5412-015-01`, `00-5412-016-02`, `00-5414-013-01`, `00-5414-014-01`, `00-5414-014-02`, `00-5414-015-01`, `00-5414-015-02`, `00-5414-016-01`, `00-5414-016-02`, `00-5416-013-01`, `00-5416-013-02`, `00-5416-014-01`, `00-5416-014-02`, `00-5416-015-01` and 25 more

Product

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."

Reason for recall

LDPE bag containing the implant adheres to the highly polished implant surface.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0838-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.