The Recall Desk
HighFDA (Devices)·Z-0101-2023·Announced 2022-10-26

DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size

Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.

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: This is an FDA Class II recall of a surgical implant where incorrect instrumentation could cause bone damage during implantation. As a risk-of-harm product where no injuries have been reported, the source text does not meet Class II hospitalization or injury criteria for a higher score.

Plain-English summary

DePuy Synthes Hammertoe Continuous Compression Implants (Product No. 46.239.001) have been recalled due to an incorrect drill guide included in the sterile kits. The affected products are distributed nationwide in the United States, with lot numbers MHC200114 (expiring 2/9/2026) and MHC220117 (expiring 3/2/2027), totaling 196 units.

The drill guide included in these implant kits is an incorrect size and will not prepare the bone correctly for the implant size included in the kit. If used during surgical implantation, the incorrect drill guide could cause improper placement of drill holes, resulting in potential bone damage.

Surgeons and medical facilities that have received these implants should stop using them immediately. Patients who have already received these implants should consult their surgeon if they have concerns about their procedure. Contact Synthes (USA) Products LLC for product replacement or guidance regarding affected lot numbers.

The recalled product

Product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
  • surgical-instrument-error
  • bone-damage-risk
  • improper-surgical-preparation

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 (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category