Device product
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
Z-1132-2016
Product summary
- Event
- Event 72900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 512
- Official record key
device-enforcement:Z-1132-2016
Official wording
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Code information: lot no.: 61932449 62126613 62204611 62213348 62406239 62203954 62204587 62332733 62236654 62406245
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.