FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
- Recall number
- Z-3171-2024
- Recalling firm
- Smith & Nephew, Inc.
- Product
- DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
- Status
- Open, Classified
- Initiated
- 2024-07-09
- Posted
- 2024-09-19
- Terminated
- not on file
- Reason
- Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
- Root cause
- Packaging change control
- Action
- Smith & Nephew issued and Urgent Medical Device Recall Notice to its consignees on 07/09/2024 via overnight mail. The notice explained the problem, potential risk, and requested the return of the product. Sales representatives, District Offices, and/or Distributors were directed to notify their customers. For questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
- Quantity
- 24 units
- Distribution
- US, Canada, Norway
- Lot, serial or model codes
- Batch 23GNX0077
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTY
- 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