Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2586-2016 — 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-trauma

U.S. FDA — Device Enforcement · United States · 2016-05-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2586-2016
Date of alert: 2016-05-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes (USA) Products LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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