BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.
This recall has been terminated (originally issued November 4, 2011).
- Company
- Biopro, Inc.
- Recall Initiated
- September 21, 2011
- Posted
- November 4, 2011
- Terminated
- February 15, 2013
- Recall Number
- Z-0163-2012
- Quantity
- 4 units
- Firm Location
- Port Huron, MI
- Official Source
- View on FDA website ↗
Reason for Recall
BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
Distribution
USA (nationwide) including the states of FL, MI, and TX.
Lot / Code Info
Item 19003, Lot 108327, Serial Number 0007-0014;
Root Cause
Packaging
Action Taken
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.