Z-0148-2026Class II

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593...

Name: Z-0148-2026 BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593...
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 (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0... 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-0148-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-10-14
Recalling firm: Biopro, Inc.
Product: BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: Part ID/ UDI-DI: 18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135 All lots and serial numbers affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0148-2026
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 LPH

K090208Class IIBiopro Femoral HeadsBiopro, Inc. / cleared 2009-05-22

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)