Z-2250-2021Class II

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

Name: Z-2250-2021 Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component
Creator: Exactech, Inc.
Published: 2021-06-29
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2021-06-29 / Completed / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component on 2021-06-29. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2250-2021
Classification: Class II
Status: Completed
Initiated: 2021-06-29
Posted: 2021-08-12
Recalling firm: Exactech, Inc.
Product: Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 29 devices
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: 6465589-6465618; 6465641

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2251-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code LZO

K050398Class IIExactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. / cleared 2005-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)