Z-0940-2018 Class II Terminated

Recalled by Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
July 21, 2017
Termination Date
March 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
255

Product Description

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

Reason for Recall

Inner and outer sterile barriers not fully sealed.

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.

Code Information

Lot: 56211103, 56211401, 56211704, 57284004