FDA Enforcement
Class II
Ongoing
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Recall: Z-3172-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3172-2024
- Event ID
- 95154
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- July 9, 2024
- Classification Date
- September 19, 2024
- Address
- 1450 E Brooks Rd, Memphis, TN, 38116-1804, United States
Description
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Reason
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Code Info
Batch 21KNX0074
Distribution
US, Canada, Norway
Quantity
73 units