RecallRadar

FDA Device recall Z-0904-2013

Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966

On 2013-03-13 the FDA classified a Class II recall of Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966 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-0904-2013
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 (Right), Part Number 487.966. 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 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.

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-0904-2013%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.