FDA Medical Device Recalls (openFDA)
Zimmer Inc: Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-01-05.
- Recall number
- Z-0120-04
- Recalling firm
- Zimmer Inc
- Product
- Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-01-05.
- Status
- Terminated
- Initiated
- 2003-10-15
- Posted
- 2004-07-20
- Terminated
- 2004-05-20
- Reason
- The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
- Root cause
- Other
- Action
- All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.
- Quantity
- not on file
- Distribution
- The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland.
- Lot, serial or model codes
- Lots 00330600, 54162100, 54382300, 55039300, 55147500, 55236100, 55417000, 60013747 and 60019270.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDW
- 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