FDA Device recall Z-1100-2016
Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD… 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-1100-2016 |
| 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 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMORAL HEAD 2 801802604 12/14 COCR FEMORAL HEAD 2 801802605 12/14 COCR FEMORAL HEAD 2 801802801 12/14 COCR FEMORAL HEAD 2 801802802 12/14 COCR FEMORAL HEAD 2 801802803 12/14 COCR FEMORAL HEAD 2 801802805 12/14 COCR FEMORAL HEAD 2 801802814 12/14 COCR FEMORAL HEAD 2 801803201 12/14 COCR FEMORAL HEAD 3 801803202 12/14 COCR FEMORAL HEAD 3 801803203 12/14 COCR FEMORAL HEAD 3 801803205 12/14 COCR FEMORAL HEAD 3 801803214 12/14 COCR FEMORAL HEAD 3 801803601 12/14 COCR FEMORAL HEAD 3 801803602 12/14 COCR FEMORAL HEAD 3 801803603 12/14 COCR FEMORAL HEAD 3 801803604 12/14 COCR FEMORAL HEAD 3 801803605 12/14 COCR FEMORAL HEAD 3 801804001 12/14 COCR FEMORAL HEAD 4 801804002 12/14 COCR FEMORAL HEAD 4 801804003 12/14 COCR FEMORAL HEAD 4 801804004 12/14 COCR FEMORAL HEAD 4 902602100 6 DEGREE COCR FEM HEAD 22 32902603935 FEM HD 26MMDIA SHT NK+ 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. 61982251 61982253 62192505 62235729 62235730 62240303 62240304 62240305 62256057 62262795 62262796 6…lot no. 61982251 61982253 62192505 62235729 62235730 62240303 62240304 62240305 62256057 62262795 62262796 62266503 62266504 62268529 62268530 62268533 62291950 62291952 62291954 62291955 62291956 62309178 62309180 62309182 62309184 62340128 62340129 62340130 62343407 62360082 62360083 62360103 62383105 62383106 62383107 62384211 62384212 61674847 62192500 62235731 62240306 62256051 62256052 62268531 62291959 62291960 62314454 62314455 62340132 62383102 62383103 62383104 62400488 61659979 61674849 62005410 62054842 62192496 62192498 62240307 62256054 62256055 62268532 62291957 62291958 62309177 62314456 62340133 62384213 62395856 62395857 62395858 62400490 61664630 62203617 62384215 62268528 62384214 61634943 62203620 62384216 62400542 62203620N 62384217 62400492 61670802 61683632 00370435N 61683632N 61660161 61670806 61670808 61670810 61683637 61817543 61817544 61817545 61820842 61873739 |
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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-1100-2016%22
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