Device product
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
Z-1126-2016
Product summary
- Event
- Event 72900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 0
- Official record key
device-enforcement:Z-1126-2016
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.: 62185968 62273370 62339644 62162469 62279774 62279774N 62221051 62279775 62279775N
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.