Z-0164-2012

BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation

Name: Z-0164-2012 BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation
Creator: Biopro, Inc.
Published: 2011-09-21
License: https://open.fda.gov/license/

Biopro, Inc. / initiated 2011-09-21 / Terminated / root cause: packaging

FDA source

Biopro, Inc. began a recall of BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation on 2011-09-21. The reason FDA records is "BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0164-2012
Status: Terminated
Initiated: 2011-09-21
Posted: 2011-11-04
Terminated: 2013-02-15
Recalling firm: Biopro, Inc.
Product: BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.
Quantity in commerce: 8 units
Distribution: USA (nationwide) including the states of FL, MI, and TX.
Product codes and lots: Item 19010, Lot 108329, Serial Number 0001-0016;

Product code JDI

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)