Z-0151-2026Class II

BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024...

Name: Z-0151-2026 BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024...
Creator: BioPro, Inc.
Published: 2025-09-09
License: https://open.fda.gov/license/

Biopro, Inc. / initiated 2025-09-09 / Open, Classified / root cause: packaging

FDA source

BioPro, Inc. began a recall of 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... on 2025-09-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0151-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-10-14
Recalling firm: Biopro, Inc.
Product: 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
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.
Quantity in commerce: 147 total
Distribution: US Domestic distribution to Texas and Michigan.
Product codes and lots: Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0151-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0148-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14
Z-0149-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14
Z-0150-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14
Z-0151-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14
Z-0152-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14
Z-0153-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14

Product code LZO

K912641Class IIBiopro Ziralloy Modular Femoral HeadsBiopro, Inc. / cleared 1991-11-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)