FDA Device recall Z-2093-2013
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70,…
- 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 profiles, several holes/length combinations (2/54, 3/70,… 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-2093-2013 |
| 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 profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. 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 | 60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485…60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485 60628439 60630043 60630090 60630091 60630093 60630095 60630098 60632496 60632513 60629728 60630092 60630094 60630096 60632497 60632504 60632506 60646243 60632516 60632527 60646247 60632505 60632514 60646241 60646245 60646256 60648988 60648990 60630045 60646250 60646257 60646260 60646261 60630097 60646251 60664579 60666551 60666553 60630101 60664586 60664589 60664591 60666539 60666552 60666554 60664584 60666570 60646255 60664594 60666550 60666568 60666555 60666557 60666567 60666540 60666544 60666546 60666547 60666548 60664611 60666569 60664616 60666542 60666543 60666556 60666560 60679361 60679362 60679363 60666545 60678765 60678768 60678771 60679351 60679353 60679364 60679345 60679348 60679359 60685057 60666558 60666561 60679349 60679354 60679357 60685086 60685089 60679352 60679360 |
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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-2093-2013%22
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