Device product
Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
Z-1127-2016
Product summary
- Event
- Event 72900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 0
- Official record key
device-enforcement:Z-1127-2016
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.: 62051735 62221046 62262799 62272099 62279770 62279770N 62079181 62162466 62185965 62185966 62221047 62262801 62262802 62262803 62279771 62285361 62311660 62393063 62279771N 62285361N 62311660N 61520812 62162464 62221048 62279772 62393064 62279772N 62393064V
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.