FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
- Recall number
- Z-2163-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
- Status
- Terminated
- Initiated
- 2018-05-04
- Posted
- not on file
- Terminated
- 2019-02-22
- Reason
- One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
- Root cause
- Error in labeling
- Action
- The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.
- Quantity
- 5 units
- Distribution
- International only: United Arab Emirates, Spain, Mexico
- Lot, serial or model codes
- 15FM16181
- 510(k) numbers
- ["K121393"]
- PMA numbers
- not on file
- Product code
- MBH
- 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