Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for us
FDA device recall Z-1162-2012 · posted 2012-03-06 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for recall
- Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Action taken
- DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAI
- Quantity affected
- 41581
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuad
- Date initiated
- 2012-01-27
- Date posted
- 2012-03-06
- Date terminated
- 2015-08-05
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PANALOK LOOP ANCHOR (K040827) | Depuy Mitek, A Johnson & Johnson Company | 2004-04-30 |