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EXPert Nail recallZ-1234-2024 · Synthes (USA) Products LLC · initiated Jan 24, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Products not sterilized, sterility cannot be confirmed

FDA root cause category: Process control

What the company is doing

DePuy Synthesis issued Urgent Medical Device Recall (Removal Letter ) via email on 1/24/24. In the US, impacted consignees will be notified via mail, sales consultants and email. OUS Affiliates will be notified via email and will inform their impacted customers per their country regulations and procedures. Letter states reason for recall, health risk and action to take: Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. Ref: 2348044 Page 2 of 3 2. Contact your DePuy Synthes Sales Consultant or contact the customer support services at [email protected] to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to [email protected] within three (3) business days of receipt of this notification. Please include in the email subject: FA 2348044. 4. Please complete the attached Business Response Form even if you do not have the subject products on hand. 5. Forward this notice to anyone in your facility that needs to be informed (e.g., those who manage, transport, store, stock, or use the subject products). 6. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 7. Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir

Recall details

Recall number
Z-1234-2024
Status
Open, Classified
Initiated by the company
Jan 24, 2024
Posted by the FDA
Mar 1, 2024
Recalling firm
Synthes (USA) Products LLC
Quantity
5 units
Product code
HSB
FDA submissions
K051678
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

Product description

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S

Code information (models, lots, serial numbers)

UDI: 10886982087331 Lot Number: 41P2222

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

10 devices cleared under K051678 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93924).

Sources and updates

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