FDA Device recall Z-1101-2016
Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIP…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIP… 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-1101-2016 |
| 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 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 12/14 UNIPOLAR FEMORAL HE 781804500 12/14 UNIPOLAR FEMORAL HE 781804600 12/14 UNIPOLAR FEMORAL HE 781804700 12/14 UNIPOLAR FEMORAL HE 781804800 12/14 UNIPOLAR FEMORAL HE 781804900 12/14 UNIPOLAR FEMORAL HE 781805000 12/14 UNIPOLAR FEMORAL HE 781805100 12/14 UNIPOLAR FEMORAL HE 781805200 12/14 UNIPOLAR FEMORAL HE 781805300 12/14 UNIPOLAR FEMORAL HE 781805400 12/14 UNIPOLAR FEMORAL HE 781805500 12/14 UNIPOLAR FEMORAL HE 781806300 12/14 UNIPOLAR FEMORAL HE 781809900 12/14 UNIPOLAR FEMORAL HE 781809901 12/14 UNIPOLAR FEMORAL HE 781809902 12/14 UNIPOLAR FEMORAL HE Product 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.62097104 62207231 62219224 62340091 62340091N 61643437 62268552 62340092 62340092N 61679532 61928512…lot no.62097104 62207231 62219224 62340091 62340091N 61643437 62268552 62340092 62340092N 61679532 61928512 62340093 62340093N 61885911 61885912 61885913 61957517 62182418 62219225 62240286 61885914 61885915 61947602 62134035 62182412 62188330 62240287 62340096 62340096N 61633850 61633854 62138595 62240289 62240809 62322617 62322617N 61545831 61630163 61986626 62240291 62329068 62329068N 61664534 61847124 61923939 62134030 62142871 62175266 62180219 62199414 62199415 62211996 62216689 62234491 62249032 62249033 62322611 62334011 62322611N 62334011N 61630305 61847131 61947598 61952494 62100692 62151857 62203217 62216691 62216692 62240302 62240810 62240811 62334008 62334008N 370550 61947601 61987197 62222767 62235720 62332949 62332950 62332949N 62332950N 61825735 61856097 62175257 62211992 62275064 61658071 61947594 62260133 62334010 62334010N 61847130 61987198 62175263 62194590 62215697 622 |
|---|
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-1101-2016%22
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