FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.
- Recall number
- Z-1617-2009
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.
- Status
- Terminated
- Initiated
- 2009-05-29
- Posted
- 2009-07-27
- Terminated
- 2009-12-22
- Reason
- The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.
- Root cause
- Packaging process control
- Action
- Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
- Quantity
- 147 of both products.
- Distribution
- Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.
- Lot, serial or model codes
- Lot Number: 60917793.
- 510(k) numbers
- ["K063251"]
- PMA numbers
- not on file
- Product code
- LPH
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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