The Recall Desk
HighFDA (Devices)·Z-0008-2023·Announced 2022-10-12

Hammertoe Continuous Compression Implant Kit Drill Pin Incompatibility

Synthes is recalling Hammertoe Continuous Compression Implant (CCI) Kits because the drill pin is incompatible with the included drill template, which may delay surgery or cause soft tissue damage and adverse tissue reactions.

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 device with potential for soft tissue damage and adverse tissue reaction. Although no reported illnesses or injuries are explicitly stated in the source, the hazard involves direct risk of harm during a surgical procedure (tissue damage, foreign material in wound), which meets the criterion for a High severity rating.

Plain-English summary

Synthes (USA) Products LLC is recalling the Hammertoe Continuous Compression Implant (CCI) Kit, Part Number 46.239.001 (UDI-DI: 00810633022047, Lot Numbers MHC220119 and MHC220120, Expiry Date 1 June 2027). The drill pin included in the kit is not compatible with the drill template due to a packaging error.

This incompatibility may result in surgical delay. Additionally, if a surgeon attempts to use the drill guide despite the tight fit, plastic debris may be created and end up in the wound, creating a potential for adverse tissue reaction. A larger incision may be required to accommodate an alternative form of fixation, which could cause soft tissue damage.

The product was distributed nationwide across the United States. Approximately 191 units were affected. Healthcare providers and patients who have received this implant kit should consult with the surgical team and manufacturer regarding appropriate next steps.

This is a Class II recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
191

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 (2)

  • UDI-DI: 00810633022047 Lot Numbers: MHC220119
  • MHC220120 Expiry Date: 1 June 2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Synthes (USA) Products LLC

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