Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF… recallZ-2251-2021 · Exactech, Inc. · initiated Jun 29, 2021
Class II Completed All recalls posted in August 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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).
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2251-2021
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Jun 29, 2021
- Posted by the FDA
- Aug 12, 2021
- Recalling firm
- Exactech, Inc.
- Quantity
- 30 devices
- Product code
- LZO
- FDA submissions
- K060107
- Distribution
- US Nationwide Distribution
Product description
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Code information (models, lots, serial numbers)
Serial Numbers: 6465619-6465640; 6465642-6465648
Other devices under the same FDA submission
4 devices cleared under K060107 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Exactech 148-28-03Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Exactech 148-28-93Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Exactech 148-32-93Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Exactech 148-36-93Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 88259).
- Z-2250-2021 · CompletedExactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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