NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX… — Class II medical device recall Z-0831-2016
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-0831-2016 |
|---|---|
| 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 | 42,064 |
| Lot numbers | 11003331, 11003479, 11004184, 11004653, 11004819, 11004864, 11004891, 11004997, 11005134, 11005150, 11005197, 11005206, 11005279, 11005343, 11005424, 11005628, 11005673, 11005698, 11005702, 11005794, 11005844, 11005855, 11005857, 11005897, 11005937, 11005939, 11005982, 11006036, 11006046, 11006061, 11006062, 11006063, 11006070, 11006106, 11006198, 11006211, 11006214, 11006272, 11006310, 11006376 and 460 more |
| Model numbers | 00-5950-012-01, 00-5950-012-02, 00-5950-013-01, 00-5950-013-02, 00-5950-013-05, 00-5950-013-06, 00-5950-014-01, 00-5950-014-02, 00-5950-014-05, 00-5950-014-06, 00-5950-015-01, 00-5950-015-02, 00-5950-015-05, 00-5950-015-06, 00-5950-016-01, 00-5950-016-02, 00-5950-016-05, 00-5950-016-06, 00-5950-017-01, 00-5950-017-02, 00-5950-017-05, 00-5950-017-06, 00-5952-012-01, 00-5952-012-02, 00-5952-013-01 and 41 more |
Product
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous 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 to: Rheumatoid 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-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex 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, 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 femoral, when used with the 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. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces."
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-0831-2016. 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.