CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Diamond Point, Both Ends K-wire recalled by Smith & Nephew
Smith & Nephew is recalling Diamond Point, Both Ends K-wire. The recall was initiated on 9 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3172-2024
- FDA event ID
- 95154
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jul 2024
- FDA classified
- 19 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Jul 2024 | Recall initiated by company | |
| 19 Sep 2024 | Classified by FDA | +72 days |
| 25 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Where it was distributed
US, Canada, Norway
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Batch 21KNX0074
Where was it sold?
US, Canada, Norway
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95154This product is part of a recall event; the main page for the event is Diamond Point, Both Ends K-wire recalled by Smith & Nephew.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diamond Point, Both Ends K-wire recalled by Smith & Nephew | Smith & Nephew | Packaging Defects | TN |
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