FDA Device recall Z-1121-2016
Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET… 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-1121-2016 |
| 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 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG 801100222 CPT MOD HD ST/ST 22MED SH 801100322 CPT MOD HD ST/ST 22MMD LN 801100122 CPT MOD HD ST/ST 22MMD SH 801100126 CPT MOD HD ST/ST 26MMD SH 801100328 CPT MOD HD ST/ST 28MMD LN 801100228 CPT MOD HD ST/ST 28MMD ME 801100128 CPT MOD HD ST/ST 28MMD SH 801100332 CPT MOD HD ST/ST 32MMD LN 801100232 CPT MOD HD ST/ST 32MMD ME 801100132 CPT MOD HD ST/ST 32MMD SH 801100100 CPT MODULAR STEM SIZE 1 S 801100200 CPT MODULAR STEM SIZE 2 S 801100300 CPT MODULAR STEM SIZE 3 S 801100400 CPT MODULAR STEM SIZE 4 S 801100500 CPT MODULAR STEM SIZE 5 S 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.: 61882616 62030937 62087634 62154310 62264269 62312479 62264269N 62033232 62097081 62264270 62303492…lot no.: 61882616 62030937 62087634 62154310 62264269 62312479 62264269N 62033232 62097081 62264270 62303492 62097082 62264271 62324103 62264271N 61833317 61936207 61942441 61955618 61964737 62024630 62024632 62028824 62028826 62028827 62028828 62041514 62041515 62041516 62042594 62042595 62043475 62094958 62094959 62103574 62103575 62105196 62105197 62106789 62118981 62121273 62121274 62122111 62148550 62148551 62240713 62249029 62255999 62284453 62094958N 62094959N 62103574N 62105196N 62105197N 62118981N 62121273N 62121274N 62122111N 62148550N 62148551N 62249029N 62255999N 62284453N 62065267 62097089 62161471 62303493 62332024 62332024N 61907672 62069520 62161473 62227021 62161473N 62227021N 61653623 61951328 62054833 62089761 62327042 62332620 62362980 62399487 62089761N 62089763 62404691 62089763N 62075382 62086078 62377682 62399485 62075382N 62086078N 62396944 60728070N 62396944V 61593 |
|---|
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-1121-2016%22
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