—#196024

Product

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

FDA product code: JDR — Staple, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K191463
Affected lot / code info: UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027

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

Root cause (FDA determination)

Employee error

Action the firm took

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 OneMD-Field-Actions@its.jnj.com 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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-08-30
Posted by FDA: 2022-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.