Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
FDA Recall Z-0942-2013 · Posted 2013-03-12
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeJEY
Date Initiated2013-01-11
Date Terminated2015-08-31
Product Quantity596
Reason for Recall
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.
Firm Action
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 [email protected].
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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