Z-0008-2023Class II

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

Name: Z-0008-2023 Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Creator: Synthes (USA) Products LLC
Published: 2022-08-30
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2022-08-30 / Open, Classified / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 on 2022-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0008-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-30
Posted: 2022-10-06
Recalling firm: Synthes (USA) Products LLC
Product: Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Product code: JDR Staple, Fixation, Bone
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 191 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0008-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0008-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-10-06

Product code JDR

K191463Class IIDePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC / cleared 2020-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)