Recall Z-1810-2008 ยท JDR Staple, Fixation, Bone
DePuy Mitek, Inc., a Johnson & Johnson Co.
Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation.
| Date | Sep 17, 2008 (initiated Apr 29, 2008) |
| Status | Terminated |
| Reason | Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage. |
| Root cause | Employee error |
| Action | DePuy Mitek notified customers by letter dated April 29, 2008 titled Urgent: Voluntary Medical Device Recall Letter asking consignees to isolate and do not use product and to return any of the identified product to DePuy Mitek using enclosed prepaid Federal Express shipping labels and to include a photocopy of the completed Business Reply Form. The firm is asking customers to complete the Business Reply Form with a self addressed, stamped envelope indicating level of inventory of the affected product and to return for immediate delivery of replacement product. If you have any questions conta |
| Quantity | 105 units |
| Distribution | Class II Recall - Worldwide Distribution --- USA including states of CA, NY, MA, NV, OH, TX, TN, MD, and countries of France, UK, Canada, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070925 | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR Depuy Mitek, A Johnson & Johnson Company, May 2, 2007 |