Recall Z-0942-2013 ยท JEY Plate, Bone
Synthes USA HQ, Inc.
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
| Date | Mar 12, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | 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 | Employee error |
| 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 FieldAction@synthes.com. |
| Quantity | 596 |
| Distribution | Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010499 | SYNTHES (USA) MIDFACE DISTRACTOR Synthes (Usa), May 3, 2001 |