FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
- Recall number
- Z-0130-2014
- Recalling firm
- Smith & Nephew Inc
- Product
- GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
- Status
- Terminated
- Initiated
- 2013-10-07
- Posted
- 2013-11-01
- Terminated
- 2016-08-23
- Reason
- Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
- Root cause
- Process control
- Action
- Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.
- Quantity
- 4 units
- Distribution
- USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
- Lot, serial or model codes
- Batch No. 13GM11272
- 510(k) numbers
- ["K951987"]
- 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