CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Femoral Nail, LEFT T2 GTN mm recalled by Stryker
Stryker is recalling Femoral Nail, LEFT T2 GTN mm, distributed nationwide in the US. The recall was initiated on 22 May 2025 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-1939-2025
- FDA event ID
- 96924
- Recalling firm
- Stryker, Selzach
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 10 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 22 May 2025 | Recall initiated by company | |
| 10 Jun 2025 | Classified by FDA | +19 days |
| 18 Jun 2025 | 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
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Product as listed by the FDA
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Where it was distributed
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Questions about this recall
Why was it recalled?
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Which lots are affected?
Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
Where was it sold?
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
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 96924| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Femoral Nail, Right T2 GTN mm recalled by Stryker | Stryker | Other | Nationwide |
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |