Hammertoe Continuous Compression Implant (CCI) Kit recallZ-0008-2023 · Synthes (USA) Products LLC · initiated Aug 30, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

FDA root cause category: Employee error

What the company is doing

DePuy Synthes issued Urgent Medical Device Recall (Removal) letter on 8/30/22. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject product and quarantine. DO NOT USE THE SUBJECT PRODUCT. 2. Contact your DePuy Synthes Sales Consultant or call the customer support services at 1-800-255-2500 to coordinate the return/credits of the subject product. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to [email protected] within 3 business days of receipt of this notification. Please include in the email subject: FA 2154225: 2022 Hammertoe CCI Kit. " Please complete the attached Business Response Form even if you do not have the subject product on hand. 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. Inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.

Recall details

Recall number: Z-0008-2023
Status: Open, Classified
Initiated by the company: Aug 30, 2022
Posted by the FDA: Oct 6, 2022
Recalling firm: Synthes (USA) Products LLC
Quantity: 191 units
Product code: JDR
FDA submissions: K191463
Distribution: US Nationwide distribution.

Product description

Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

N/A Standard
Synthes GmbH · Staple, Fixation, Bone
2 recalls16 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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