FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244
- Recall number
- Z-1284-03
- Recalling firm
- Biomet, Inc.
- Product
- Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244
- Status
- Terminated
- Initiated
- 2003-06-18
- Posted
- 2003-09-24
- Terminated
- 2003-09-23
- Reason
- The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Root cause
- Other
- Action
- Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
- Quantity
- 33
- Distribution
- United States
- Lot, serial or model codes
- 255928, 269737, 300486, 326364, 331233, 349386, 378840, 381381, 386128, 389269, 389270, 422994, 429482, 429483, 429484, 429485, 429488, 429558, 445460, 449848, 449850, 449853, 449854
- 510(k) numbers
- ["K911684"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 1825034
- 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