FDA Medical Device Recalls (openFDA)
Zimmer Inc.: TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
- Recall number
- Z-2439-2010
- Recalling firm
- Zimmer Inc.
- Product
- TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
- Status
- Terminated
- Initiated
- 2010-07-05
- Posted
- 2010-09-20
- Terminated
- 2010-12-22
- Reason
- Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.
- Root cause
- Labeling mix-ups
- Action
- Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.
- Quantity
- 50 total
- Distribution
- Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.
- Lot, serial or model codes
- Lot: 60683028, Manufactured: 6/05/2007
- 510(k) numbers
- ["K040630"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- 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