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Completed

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

FDA Recall Z-2250-2021 · Posted 2021-08-12

Recalling FirmExactech, Inc.
Recall StatusCompleted
Product CodeLZO
Date Initiated2021-06-29
Product Quantity29 devices

Reason for Recall

Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

Firm Action

The firm notified their direct consignees on 06/29/2021 by email. The letter requested return of the affected devices. The firm will issue a letter through the sales representatives to the implanting physicians to follow-up with the patients beginning 07/23/2021.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050398EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADSExactech, Inc. · 2005-11-18

Official Source

View FDA Recall →

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

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