FDA Medical Device Recalls (openFDA)
Omnilife Science Inc.: Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
- Recall number
- Z-2241-2014
- Recalling firm
- Omnilife Science Inc.
- Product
- Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
- Status
- Terminated
- Initiated
- 2014-05-09
- Posted
- 2014-08-15
- Terminated
- 2014-08-19
- Reason
- Staining on hip implant.
- Root cause
- Manufacturing material removal
- Action
- All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.
- Quantity
- 13 devices
- Distribution
- US: CA, OK, VA, FL, MA, NY, TX
- Lot, serial or model codes
- Lot: 17284
- 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