Device product
Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL For use in total hip arthroplasty
Z-1123-2016
Product summary
- Event
- Event 72900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1123-2016
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.: 62233575 62255244
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.