TI Single Vector Distractor Proximal Foot/Left — Class II medical device recall Z-2586-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-08-24, distributed nationwide. DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vect
| Recall number | Z-2586-2016 |
|---|---|
| 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 | 2016-05-23 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH |
| Quantity | 599 units |
| Lot numbers | 14MAY1999, 22APR2015, 22APR2035, 3959732, 3959733, 4038566, 4044600, 4095085, 4418691, 4479352, 4597089, 4767010, 4851967, 4851968, 5277361, 5346057, 5419963, 5433149, 5445352, 5445632, 5445638, 5785469, 5785471, 5828442, 5828447, 5847302, 5847357, 5883452, 6107608, 6107609, 6107614, 6107615, 6141641, 6141642, 6164420, 6164421, 6819614, 7489031, 7537257, 7865426 and 3 more |
| Model numbers | 487.975 |
| Expiration dates | 2019-10-06 |
Product
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
Reason for recall
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
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-2586-2016. 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.