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Terminated

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

FDA Recall Z-0905-2013 · Posted 2013-03-01

Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeDZL
Date Initiated2013-01-11
Date Terminated2015-08-31
Product Quantity18

Reason for Recall

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

Firm Action

The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010690SYNTHES TITANIUM MULTI-VECTOR DISTRACTORSynthes (Usa) · 2001-05-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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