—#115763

Product

Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.

FDA product code: JEY — Plate, Bone
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K010499
Affected lot / code info: All Lots

Why it was recalled

There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.

Root cause (FDA determination)

Employee error

Action the firm took

The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to all consignees. The letter identified the affected product and the problem. Also, the firm requested consignees to examine their inventory for products(s) with the specified part number, remove them from use, and return them to Synthes. Customers were to follow the instructions provided on what to do if they have or do not have any identified affected product. Questions should be directed to 610-719-5450 or FieldAction@synthes.com.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.

Timeline

Recall initiated: 2013-01-11
Posted by FDA: 2013-03-12
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115763. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.