FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
- Recall number
- Z-2625-2017
- Recalling firm
- Smith & Nephew, Inc.
- Product
- LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
- Status
- Terminated
- Initiated
- 2017-05-30
- Posted
- 2017-06-12
- Terminated
- 2021-12-10
- Reason
- The incorrect Loctite adhesive was used to assemble the impactor heads.
- Root cause
- Process control
- Action
- The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.
- Quantity
- 46 units
- Distribution
- US distribution to TN
- Lot, serial or model codes
- Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007
- 510(k) numbers
- ["K162775"]
- PMA numbers
- not on file
- Product code
- JWH
- 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