FDA Medical Device Recalls (openFDA)
Omni Life Science: Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
- Recall number
- Z-2370-2012
- Recalling firm
- Omni Life Science
- Product
- Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
- Status
- Terminated
- Initiated
- 2012-08-09
- Posted
- 2012-09-13
- Terminated
- 2013-01-10
- Reason
- The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Root cause
- Packaging
- Action
- Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.
- Quantity
- 312 units
- Distribution
- Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
- Lot, serial or model codes
- Lot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547
- 510(k) numbers
- ["K094017"]
- PMA numbers
- not on file
- Product code
- JWH
- 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