FDA Medical Device Recalls (openFDA)
Biopro, Inc.: BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.
- Recall number
- Z-0163-2012
- Recalling firm
- Biopro, Inc.
- Product
- BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.
- Status
- Terminated
- Initiated
- 2011-09-21
- Posted
- 2011-11-04
- Terminated
- 2013-02-15
- Reason
- BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
- 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
- 4 units
- Distribution
- USA (nationwide) including the states of FL, MI, and TX.
- Lot, serial or model codes
- Item 19003, Lot 108327, Serial Number 0007-0014;
- 510(k) numbers
- ["K090208"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 1832656
- Firm city
- Port Huron
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28