DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood C
FDA device recall Z-1071-2010 · posted 2010-03-11 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility
- Action taken
- DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 194 units
- Distribution
- LA & MS
- Date initiated
- 2009-12-09
- Date posted
- 2010-03-11
- Date terminated
- 2010-05-20
- Location
- Powell, TN
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