Device product

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

Z-1160-2016

January 11, 2016

Class II

Product summary

Firm: Zimmer Manufacturing B.V.
Event: Event 72900
Status: Terminated
Classification: Class II
Quantity: 400
Official record key: device-enforcement:Z-1160-2016

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.: 62313588

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.