—#188228

Product

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

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K050398
Affected lot / code info: Serial Numbers: 6465589-6465618; 6465641

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2021-06-29
Posted by FDA: 2021-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188228. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.