Device product

Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737

Z-0940-2018

July 21, 2017

Class II

Product summary

Firm: Howmedica Osteonics Corp.
Event: Event 79038
Status: Terminated
Classification: Class II
Quantity: 255
Official record key: device-enforcement:Z-0940-2018

Official wording

Reason: Inner and outer sterile barriers not fully sealed.

Code information: Lot: 56211103, 56211401, 56211704, 57284004

Distribution pattern: Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Inner and outer sterile barriers not fully sealed.