Z-0152-2026Class II

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC...

Name: Z-0152-2026 BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC...
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 Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO... 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-0152-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-10-14
Recalling firm: Biopro, Inc.
Product: BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36
Product code: LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
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 13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296 All lots, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0152-2026
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 LZY

K954768Class IIBiopro Hemi-Endo Modular Ceramic HeadBiologically Oriented Prostheses / cleared 1996-01-18

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)