FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-53-45 (00225305345).
- Recall number
- Z-1335-06
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-53-45 (00225305345).
- Status
- Terminated
- Initiated
- 2006-06-26
- Posted
- 2006-08-03
- Terminated
- 2007-12-05
- Reason
- Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Root cause
- Other
- Action
- Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
- Quantity
- 310 total for all catalog numbers
- Distribution
- Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
- Lot, serial or model codes
- Lots 24122200, 24730600, 25342400, 25765300, 60025157 and 60034732. ********Extended to include lots 24122600, 24122700, 24123000, 24667300, 24730700, 24730800, 25769900, 26003200, 26113700, 26435200, 60005229, 60019022, 60034734, 60034735, 60043306, 60043307 and 60043308.*********************
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDJ
- 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