FDA Device recall Z-1127-2016
Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORA…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORA… by Zimmer Manufacturing B V, citing as a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1127-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | US |
Product
Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
Reason
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Identifiers
| code_info | lot no.: 62051735 62221046 62262799 62272099 62279770 62279770N 62079181 62162466 62185965 62185966 62221047…lot no.: 62051735 62221046 62262799 62272099 62279770 62279770N 62079181 62162466 62185965 62185966 62221047 62262801 62262802 62262803 62279771 62285361 62311660 62393063 62279771N 62285361N 62311660N 61520812 62162464 62221048 62279772 62393064 62279772N 62393064V |
|---|
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-1127-2016%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.