FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
- Recall number
- Z-1704-2009
- Recalling firm
- Smith & Nephew Inc
- Product
- IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
- Status
- Terminated
- Initiated
- 2009-01-22
- Posted
- 2009-08-04
- Terminated
- 2011-08-18
- Reason
- Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.
- Root cause
- Process design
- Action
- Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.
- Quantity
- 99 units
- Distribution
- Distribution to USA, Switzerland and Australia.
- Lot, serial or model codes
- Lot Number: 08K22270
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- 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