FDA Device recall Z-0849-2016
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained,…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained,… 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-0849-2016 |
| 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
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
Reason
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item numbers: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-…Item numbers: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-013-06 00-7843-013-08 00-7843-013-36 00-7843-014-06 00-7843-014-08 00-7843-014-36 00-7843-015-06 00-7843-015-08 00-7843-015-36 00-7843-016-06 00-7843-016-08 00-7843-016-36 00-7843-017-06 00-7843-017-08 00-7843-017-36 00-7843-018-06 00-7843-018-08 00-7843-018-36 00-7843-019-06 00-7843-019-36 00-7843-020-06 00-7843-020-08 00-7843-020-36 00-7843-021-06 00-7843-021-36 00-7843-022-06 00-7843-022-36 Lot numbers: 11003968 11003975 11004089 11004219 11004274 11004333 11004746 11005067 11005118 11008034 61669552 61669554 61669559 61669561 61669563 61695978 61699465 61704396 61704397 61714436 61721717 61721719 61721720 61729915 61729916 61729917 61729919 61735802 61735816 61735817 61735818 61741801 61741802 61741815 61746858 61746859 61746860 61746875 61746876 61746878 61746888 61746890 61746892 61752717 617 |
|---|
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-0849-2016%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.