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Terminated

BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.

FDA Recall Z-0163-2012 · Posted 2011-11-04

Recalling FirmBiopro, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2011-09-21
Date Terminated2013-02-15
Product Quantity4 units

Reason for Recall

BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.

Firm 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.

Root Cause

Packaging

Distribution Pattern

USA (nationwide) including the states of FL, MI, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090208BIOPRO FEMORAL HEADSBiopro, Inc. · 2009-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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