Recall Z-2251-2021— Exactech, Inc.

Name: FDA recall Z-2251-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-29

Class II · Completed

Class II FDA medical device recall by Exactech, Inc., initiated 2021-06-29. It names one FDA 510(k) clearance: K060107. Product: Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.. Reason: 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)..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Completed
Initiated: 2021-06-29
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K060107 — MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADSExactech, Inc.·cleared 2006-02-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.