CLASS II ONGOING Device recall · Reported 22 Mar 2023 · FDA Enforcement Report
Tfn-Advanced Femoral Nail/130 Deg TI Cann Tfna Sterile recalled
Synthes (USA) Products is recalling Tfn-Advanced Femoral Nail/130 Deg TI Cann Tfna Sterile, distributed nationwide in the US. The recall was initiated on 1 Feb 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-1248-2023
- FDA event ID
- 91702
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Feb 2023
- FDA classified
- 10 Mar 2023
- Reported
- 22 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 10 Mar 2023 | Classified by FDA | +37 days |
| 22 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Product as listed by the FDA
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
Where it was distributed
Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
Questions about this recall
Why was it recalled?
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Which lots are affected?
UDI-DI: 10886982097262 Lot Number: 610P788
Where was it sold?
Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
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
2 other products · FDA event 91702This product is part of a recall event; the main page for the event is Tfn-Advanced Femoral Nail/125 Deg TI Cann Tfna Sterile recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tfn-Advanced Femoral Nail/125 Deg TI Cann Tfna Sterile recalled | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Tfn-Advanced Femoral Nail/125 Deg TI Cann Tfna - Sterile recalled | Synthes (USA) Products | Other | Nationwide |
More recalls from Synthes (USA) Products
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|---|---|---|---|---|---|
| Device | CLASS II | 2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
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 |