FDA Device recall Z-2583-2016
TI Single Vector Distractor Body with Right Foot/30mm
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of TI Single Vector Distractor Body with Right Foot/30mm by Synthes Usa Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2583-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-23 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 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
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.
Identifiers
| code_info | Part #487.964, Lot # A4JV280; 4038562; 4091232; 4095219; 4454474; 4485940; 4538241; 5021030; 5041163; 5051836; 5140379;…Part #487.964, Lot # A4JV280; 4038562; 4091232; 4095219; 4454474; 4485940; 4538241; 5021030; 5041163; 5051836; 5140379; 5175699; 5292906; 5321397; 5321398; 5321399; 5332085; 5391292; 5505143; 5505144; 5505147; 5559642; 5559649; 5559854; 5559855; 5559856; 5621111; 5621115; 5621126; 5621127; 5621128; 5621130; 5868674; 6250788; 6250789; 6250793; 6397763; 6538895; 6551653; 6720328; 6932326; 7489023; 7489024; 7609552; A4JY067, Mfg date 17MAY1999 - 04SEP2014, Exp. date 22MAR2020-04SEP2034 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2583-2016%22
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