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Terminated

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535

FDA Recall Z-0941-2018 · Posted None

Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2017-07-21
Date Terminated2020-03-12
Product Quantity255

Reason for Recall

Inner and outer sterile barriers not fully sealed.

Firm Action

Recall notices were sent to customers with a request to return all affected product.

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121308HIP SYSTEMSHowmedica Osteonics Corp. · 2012-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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