CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Femoral Head (Ceramic heads 28-30) Product ID/Description recalled
BioPro is recalling Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 Head Femoral Ceramic -3, distributed in Michigan, Texas. The recall was initiated on 9 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0151-2026
- FDA event ID
- 97605
- Recalling firm
- BioPro, Port Huron, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2025
- FDA classified
- 14 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 9 Sep 2025 | Recall initiated by company | |
| 14 Oct 2025 | Classified by FDA | +35 days |
| 22 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
Where it was distributed
US Domestic distribution to Texas and Michigan.
Questions about this recall
Why was it recalled?
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Which lots are affected?
Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers
Where was it sold?
US Domestic distribution to Texas and Michigan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97605This product is part of a recall event; the main page for the event is Bipolar Head Product ID/Description 18130 Bipolar Head recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bipolar Head Product ID/Description 18130 Bipolar Head recalled | BioPro | Sterility | MI, TX | |
| CLASS II | Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro | BioPro | Sterility | MI, TX | |
| CLASS II | Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro | BioPro | Sterility | MI, TX | |
| CLASS II | Femoral Head Product ID/Description 14089 Head Femoral recalled | BioPro | Sterility | MI, TX | |
| CLASS II | Endo Head (Metal uni-polar, 38-55) Product recalled by BioPro | BioPro | Sterility | MI, TX |
More recalls from BioPro
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Endo Head (Metal uni-polar, 38-55) Product recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head Product ID/Description 14089 Head Femoral recalled | BioPro | Sterility | MI, TX |
| Device | CLASS II | Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Bipolar Head Product ID/Description 18130 Bipolar Head recalled | BioPro | Sterility | MI, TX |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |