Z-1160-2016 Class II Terminated
FDA device recall Z-1160-2016 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: 400.
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
- 400
Product Description
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total 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.: 62313588