FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
- Recall number
- Z-0265-2022
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
- Status
- Open, Classified
- Initiated
- 2021-10-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- The labels on the packages of screws were switched.
- Root cause
- Error in labeling
- Action
- The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete.
- Quantity
- 224 units
- Distribution
- Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
- Lot, serial or model codes
- REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.
- 510(k) numbers
- ["K162078"]
- 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