Recall Z-3172-2024— Smith & Nephew, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2024-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-09
- Firm location
- Memphis, TN, United States
Product description
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.