Recalls / —

—#116033

Product

Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.

FDA product code

DZL — Screw, Fixation, Intraosseous

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K010690

Affected lot / code info

Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Synthes USA HQ, Inc.

Address

1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern

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

Timeline

Recall initiated

2013-01-11

Posted by FDA

2013-03-01

Terminated

2015-08-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #116033. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.