FDA Device recall Z-2094-2013
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/1…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/1… 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-2094-2013 |
| 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
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., 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 | 60619089 60619099 60611043 60619098 60611039 60632532 60668205 60668241 60669598 60668240 60668247 60685095…60619089 60619099 60611043 60619098 60611039 60632532 60668205 60668241 60669598 60668240 60668247 60685095 60685102 60679344 60685066 60685104 60685096 60674425 60704366 60704367 60704370 60714913 60704368 60714914 60714915 60714916 60726325 60744850 60714917 60726326 60754395 60763214 60763215 60763216 60787010 60787191 60787194 60787198 60787190 60787192 60787193 60787196 60787199 60787197 60787189 60803585 60807846 60807848 60803584 60787195 60815493 60845778 60845777 60844062 60868471 60877490 60877489 60885169 60885171 60911343 60932392 60932393 60938417 60938419 60943339 60938421 60944523 60787188 60972802 60972803 60998290 61005007 60972801 61020337 61020339 61020335 61037487 61037488 61037489 61041090 61037490 61027502 61027507 61027516 61041091 61027510 61027523 61027511 60868468 61076083 61086851 61041093 61092223 61092239 61092241 61103196 61103197 61103198 61103201 61101549 |
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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-2094-2013%22
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