FDA Device recall Z-2091-2013
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree… by Zimmer, citing single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-19 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.
Reason
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Identifiers
| code_info | 60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511…60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2013%22
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