FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
- Recall number
- Z-1701-2009
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
- Status
- Terminated
- Initiated
- 2009-06-05
- Posted
- 2009-08-04
- Terminated
- 2009-12-22
- Reason
- Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
- Root cause
- Process control
- Action
- Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
- Quantity
- 120 of both products
- Distribution
- Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
- Lot, serial or model codes
- Lots 60633223 and 60740476.
- 510(k) numbers
- ["K032367"]
- PMA numbers
- not on file
- Product code
- HSB
- 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