Recall Z-0161-06 ยท LXH Orthopedic Manual Surgical Instrument
Depuy Mitek, a Johnson & Johnson Co.
DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220
| Date | Nov 18, 2005 (initiated Aug 9, 2005) |
| Status | Terminated |
| Reason | Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer |
| Root cause | Other |
| Action | DePuy Mitek notified the accounts by US Mail on 8/09/05. Accounts were requested to return product. |
| Quantity | 5 boxes /10 units (50 pieces) |
| Distribution | CA, NC, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.