Recall Z-2211-2011 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral
| Date | May 19, 2011 (initiated Feb 24, 2011) |
| Status | Terminated |
| Reason | Metal debris in the shaft component of the device |
| Root cause | Manufacturing material removal |
| Action | DePuy Mitek sent an Urgent Voluntary Product Recall Notification letter dated February 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check their inventory to determine if they have any affected product. Customers were asked to complete the enclosed business reply form and fax it to 508-828-3750 or email to mitekcomplaints@its.jnj.com whether or not they have any of the affected product remaining in their inventory. Customers were asked to utilize the return good authoriz |
| Quantity | 4141 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090124 | GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 Depuy Mitek, A Johnson & Johnson Company, Mar 11, 2009 |