Z-0153-2026Class II

BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD...

Name: Z-0153-2026 BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD...
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 Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT... 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-0153-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-10-14
Recalling firm: Biopro, Inc.
Product: BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 All lots, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2026
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 JDI

K872856Class IIBiopro 32Mm BallBiopro, Inc. / cleared 1987-08-17

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)