FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
- Recall number
- Z-0548-2022
- Recalling firm
- Smith & Nephew, Inc.
- Product
- INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
- Status
- Open, Classified
- Initiated
- 2022-01-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
- Root cause
- Process control
- Action
- The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.
- Quantity
- 8 units (US)
- Distribution
- US Nationwide distribution in the states of CA and OH.
- Lot, serial or model codes
- UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
- 510(k) numbers
- ["K073375"]
- PMA numbers
- not on file
- Product code
- HRS
- 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