FDA Medical Device Recalls (openFDA)
Omnilife Science Inc.: Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
- Recall number
- Z-2064-2015
- Recalling firm
- Omnilife Science Inc.
- Product
- Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
- Status
- Terminated
- Initiated
- 2015-06-03
- Posted
- 2015-07-14
- Terminated
- 2015-09-08
- Reason
- Product may breach the inner and outer sterile pouches during shipping or handling.
- Root cause
- Packaging
- Action
- All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to cflores@omnils.com.
- Quantity
- 146 devices
- Distribution
- US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
- Lot, serial or model codes
- Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
- 510(k) numbers
- ["K090845"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3008342029
- Firm city
- East Taunton
- Firm state
- MA
- 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