smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
- Company
- Smith & Nephew Inc
- Recall Initiated
- October 2, 2024
- Posted
- October 31, 2024
- Recall Number
- Z-0281-2025
- Quantity
- 5 units
- Firm Location
- Memphis, TN
Reason for Recall
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Distribution
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
Lot / Code Info
UDI/DI 03596010469212, Batch number 23LM02331
Root Cause
Packaging change control
Action Taken
Smith & Nephew issued an "Urgent Medical Device RECALL Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 Distributors, sales reps, and district offices were directed to notify their customers. If you have any questions or concerns regarding this recall, please contact FieldActions@smith nephew.com.