Recall StatusTerminated
Date Initiated2010-12-03
Date Terminated2013-04-02
Product Quantity92,000 units (920 boxes/100)
Reason for Recall
Product sterility may be compromised due to breach in sterile packaging
Firm Action
Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product.
Customers were instructed to return all identified affected product to:
DePuy Mitek
ATTN: Recall Coordinator
50 Scotland Boulevard
Bridgewater, MA 02324
Record their assigned return material authorization (RMA) number on the outer shipping box.
Use the Prepaid Federal Express shipping label for the return of the product.
Include a photo copy of the completed business reply form.
For questions or concerns call 1-800-382-4682, PROMPT 3.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.
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.