Device product
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
Z-1137-2016
Product summary
- Event
- Event 72900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-1137-2016
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.: 62065298 62221052 62221052N 62093457 62185967 62268539 62334044 62268539N 61555436 62162471 62221049 62268540 62285362 62268540N 62285362N
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.