Atlas FDA

DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220

FDA device recall Z-0161-06 · posted 2005-11-18 · Terminated

Recall details

Recalling firm
Depuy Mitek, a Johnson & Johnson Co.
Reason for recall
Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
Action taken
DePuy Mitek notified the accounts by US Mail on 8/09/05. Accounts were requested to return product.
Root cause
Other
Status
Terminated
Product code
LXH
Quantity affected
5 boxes /10 units (50 pieces)
Distribution
CA, NC, VA
Date initiated
2005-08-09
Date posted
2005-11-18
Date terminated
2006-05-02
Location
Raynham, MA

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