CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report
Trigen Trochanteric Antegrade Nail Lime 130 Degree Left recalled
Smith & Nephew is recalling Trigen Trochanteric Antegrade Nail Lime 130 Degree Left, distributed in California, Delaware, Pennsylvania. The recall was initiated on 24 Jul 2023 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-2443-2023
- FDA event ID
- 92767
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2023
- FDA classified
- 22 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2023 | Recall initiated by company | |
| 22 Aug 2023 | Classified by FDA | +29 days |
| 30 Aug 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT 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
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Where it was distributed
US, AE, CA, DE, ES, GB, MX, PA, PL
Questions about this recall
Why was it recalled?
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
Which lots are affected?
UDI/DI 03596010500922, Batch Number 21KSM0598
Where was it sold?
US, AE, CA, DE, ES, GB, MX, PA, PL
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 92767| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Trigen Trochanteric Antegrade Nail Lime 130 Degree Left recalled | Smith & Nephew | Packaging Defects | CA, DE, PA |
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