RecallRadar

FDA Device recall Z-0905-2013

Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967

On 2013-03-13 the FDA classified a Class II recall of Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967 by Synthes Usa Hq, citing it was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0905-2013
ClassificationClass II
Statusterminated
Initiated2013-01-11
Published2013-03-13
Last updated2026-09-13 11:53 UTC
CompanySynthes Usa Hq
DistributionUS

Product

Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

Reason

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

Identifiers

code_infoPart number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.