Z-0149-2026Class II

BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181...

Name: Z-0149-2026 BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181...
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 (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184... 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-0149-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-10-14
Recalling firm: Biopro, Inc.
Product: BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55
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: Product ID/UDI-DI 10179 M20910179 10180 M20910180 10181 M20910181 10182 M20910182 10183 M20910183 10184 M20910184 10185 M20910185 10186 M20910186 10187 M20910187 10188 M20910188 10189 M20910189 10190 M20910190 10191 M20910191 10192 M20910192 10193 M20910193 10194 M20910194 10195 M20910195 10196 M20910196 All lots, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0149-2026
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

K895886Class IIBiopro Hemi-Endo Modular Head for Psl SystemBiopro, Inc. / cleared 1989-12-01

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)