Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced — Class II medical device recall Z-2214-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-07-27, distributed nationwide. DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.
| Recall number | Z-2214-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-06-07 |
| Classified | 2016-07-15 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-04-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,064 units |
| Lot numbers | 9066399, 9066435, 9301183, 9301184, 9327510, 9339162, 9340629, 9347641, 9347642, 9351396, 9351397, 9359339, 9359540, 9371095, 9409790, 9409791, 9409792, 9422885, 9428332, 9439269, 9485532, 9485534, 9494322, 9501935, 9505477, 9519303, 9519308, 9533341, 9542998, 9554329, 9554330, 9569617, 9569618, 9574931, 9590744, 9590747, 9604306, 9604307, 9620447, 9641077 and 7 more |
| Model numbers | 03.037.017 |
Product
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306 These devices are specific to the Trochanteric Fixation Nail Advanced (TFNA) system. The TFNA Proximal Femoral Nailing System is for the treatment of intramedullary fixation of proximal femoral fractures
Reason for recall
DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2214-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.