FDA Device recall Z-1061-2018
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ… by Zimmer Biomet, citing the LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant af….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1061-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-29 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT 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).
Reason
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Identifiers
| code_info | 00-5412-015-02 61777756 00-5412-015-02 11003149 00-5412-015-02 61782977 00-5412-015-02 61796047 00-5412-015-02 6180…00-5412-015-02 61777756 00-5412-015-02 11003149 00-5412-015-02 61782977 00-5412-015-02 61796047 00-5412-015-02 61806563 00-5412-015-02 61806562 00-5412-015-02 61867212 00-5412-015-02 61867213 00-5412-015-02 61872035 00-5412-015-02 61871424 00-5412-015-02 11004422 00-5412-015-02 11004477 00-5412-015-02 61876226 00-5412-015-02 61885240 00-5412-015-02 61889370 00-5412-015-02 61894436 00-5412-015-02 61899511 00-5412-015-02 11001440 00-5412-015-02 61904154 00-5412-015-02 61916029 00-5412-015-02 61921361 00-5412-015-02 61928677 00-5412-015-02 61940207 00-5412-015-02 61952635 00-5412-015-02 61963807 00-5412-015-02 61968948 00-5412-015-02 61988106 00-5412-015-02 11005840 00-5412-015-02 61983536 00-5412-015-02 61975655 00-5412-015-02 61995014 00-5412-015-02 61988107 00-5412-015-02 62001897 00-5412-015-02 62013575 00-5412-015-02 62005775 00-5412-015-02 62013586 00-5412-015-02 62013587 00-5412-015-02 11006300 00-5412-015-02 62020383 00-5412-015-02 62025800 |
|---|
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-1061-2018%22
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