FDA Device recall Z-2092-2013
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread,…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread,… 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-2092-2013 |
| 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 FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. 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 | 60550146 60585234 60585240 60621358 60612822 60585235 60612824 60585239 60629949 60629951 60573157 60612823…60550146 60585234 60585240 60621358 60612822 60585235 60612824 60585239 60629949 60629951 60573157 60612823 60612832 60629948 60629756 60629755 60629950 60560744 60621346 60621347 60621348 60621350 60612826 60621349 60621351 60621353 60585244 60612820 60612830 60621354 60621356 60621357 60612825 60612829 60612831 60653083 60653092 60653075 60653078 60653085 60653088 60653100 60653111 60539408 60539409 60653095 60653098 60653107 60653110 60653114 60653116 60653115 60653121 60671979 60671980 60653146 60671982 60561143 60653108 60653109 60653119 60653123 60653124 60653125 60653130 60653134 60653135 60653136 60653139 60653143 60653104 60653118 60653127 60682963 60671976 60653117 60653129 60653132 60661882 60671959 60671977 60671962 60671967 60653142 60621355 60653141 60671965 60671963 60671964 60523364 60612818 60653131 60671961 60615110 60653133 60653140 60536820 60671970 60671978 60671969 |
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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-2092-2013%22
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