FDA Device recall Z-0125-2016
Inserter for Titanium Elastic Nails (TEN), orthopedic device
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Inserter for Titanium Elastic Nails (TEN), orthopedic device by Synthes Usa Products, citing potential for mechanical failures such as breakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0125-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-03 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Reason
potential for mechanical failures such as breakage.
Identifiers
| code_info | Part Number 359.219 lot numbers: 1095607 3301017 4826021 5422955 5718485 8006578 8017872 1121876 3325276 4911859 545…Part Number 359.219 lot numbers: 1095607 3301017 4826021 5422955 5718485 8006578 8017872 1121876 3325276 4911859 5455364 5718486 8007139 8018319 1641700 3382583 4911860 5455365 5718487 8007472 8114862 1806500 3410330 4969014 5485078 7505411 8008046 8214803 1811056 3430483 4971314 5492810 7565990 8008261 8326267 1811059 3493588 5042001 5496455 7601112 8009205 8424513 1813900 3504996 5066417 5507788 7619995 8009363 8476286 1904339 3524633 5066418 5525235 7670741 8009859 8541845 3005674 3619119 5090224 5545372 7675623 8012109 8608192 3005675 3626055 5090226 5555604 7727696 8012353 8608193 3009312 3659645 5106335 5569028 7774491 8012925 8768253 3020674 3706611 5123586 5611445 7810649 8013244 8973607 3025607 3797835 5123587 5611446 7845943 8014078 9275702 3051190 4321659 5162204 5611447 7874224 8014645 A8LA901 3054608 4340451 5162205 5641429 7896075 8015605 A8MA648 3065013 4389269 5162206 5641430 7979727 8015831 A8MB744 3069566 4466686 5162760 5657073 8000136 8016063 A8NA0 |
|---|
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-0125-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.