The Recall Desk
HighFDA (Devices)·Z-1248-2023·Announced 2023-03-22

TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with dimensional accuracy mismatch in a critical surgical implant. No illnesses or injuries have been reported, making this a High rather than Severe severity. The hazard is significant but currently theoretical.

Plain-English summary

Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails (12MM/130 DEG, TFNA 170MM) because the nails have been labeled and etched with incorrect length measurements. Some nails labeled and etched as 200mm may actually measure 170mm in length, while some labeled and etched as 170mm may actually measure 200mm.

These nails are used for temporary fixation and stabilization of proximal femur fractures during orthopedic surgery. Dimensional accuracy is critical in surgical implants to ensure proper fixation and patient outcomes. The dimensional mismatch between the label and the actual product could result in improper surgical fixation, requiring revision surgery or leading to complications such as malunion or nonunion.

The recalled product (UDI-DI: 10886982097262, Lot 610P788) was distributed worldwide, including in the United States (Mississippi, Oregon, Texas), Canada, and Japan. Six units were affected by this recall.

Orthopedic surgeons and surgical teams should verify the actual dimensions of nails before use, particularly for this lot number. Hospitals and surgical facilities should quarantine the affected lot and review surgical records from patients who may have received the incorrect implant dimensions.

The recalled product

Product
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
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Surgical Implant / Orthopedic
Hazard
  • dimension-mismatch
  • labeling-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 10886982097262 Lot Number: 610P788

Distribution

Distributed nationwide across the United States.

Related recalls

Same category