Data Foundry

Medical device recalls 2013

Synthes Multi-Vector Distractor Body — Class II medical device recall Z-0903-2013

Terminated recall by Synthes USA HQ, Inc., reported 2013-03-13, distributed nationwide. It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product speci

Recall numberZ-0903-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSynthes USA HQ, Inc., West Chester, PA, United States
Recall initiated2013-01-11
Classified2013-03-01
Reported by FDA2013-03-13
Terminated2015-08-31
DistributedNationwide (US)
Quantity2
Lot numbers7667285, 7750064, 7806090, 7826459
Model numbers487.831, 487.931

Product

Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.

Reason for recall

It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

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-0903-2013. 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.