FDA Device recall Z-0842-2016
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is ind…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is ind… by Zimmer Biomet, citing LDPE bag containing the implant adheres to the highly polished implant surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0842-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing 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 porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. " Specific uses with CR-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 CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees."
Reason
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item numbers: 00-5930-010-01 00-5930-010-02 00-5930-020-01 00-5930-020-02 00-5930-030-01 00-5930-030-02 00-5930-…Item numbers: 00-5930-010-01 00-5930-010-02 00-5930-020-01 00-5930-020-02 00-5930-030-01 00-5930-030-02 00-5930-040-01 00-5930-040-02 00-5930-040-41 00-5930-040-42 00-5930-050-01 00-5930-050-02 00-5930-060-01 00-5930-060-02 00-5930-070-01 00-5930-070-02 00-5930-080-01 00-5930-080-02 Lot numbers: 11002165 11002170 11002753 11002755 11004006 11004022 11004039 11004084 11004256 11004347 11004558 11004696 11005020 11005211 11005470 11005509 11005570 11005571 11005811 11006243 11006977 11007624 61785664 61785665 61785666 61785667 61790305 61790857 61795385 61800855 61800872 61803287 61806782 61812454 61812455 61812456 61812463 61812467 61812468 61812471 61818233 61818234 61822441 61822442 61822449 61822451 61822452 61827033 61827040 61827041 61827045 61827085 61827094 61827096 61833079 61833080 61833081 61833102 61833105 61833106 61833108 61833110 61833112 61833116 61833119 61833155 61837978 61837979 6 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0842-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.