Z-1126-2016 Class II Terminated
FDA device recall Z-1126-2016 was initiated by Zimmer Manufacturing B.V. on January 11, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 13, 2017). Affected quantity: 0.
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- January 11, 2016
- Termination Date
- April 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
lot no.: 62185968 62273370 62339644 62162469 62279774 62279774N 62221051 62279775 62279775N