CODMAN recallZ-2224-2021 · Integra LifeSciences Corp. · initiated Jun 1, 2021
Terminated
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 Integra LifeSciences Corp. 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
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
FDA root cause category: Process change control
What the company is doing
Integra notified consignees (Hospitals, Government facilities, and Distributors) by letter via FedX 2 Day Mail on June 1, 2021 and email to Distributor. Letter states reason for recall, health risk and action to take: We request that you take the following actions: 1. Customers a. If you do have units of the affected product listed in Table 1, remove it immediately from service. b. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. c. If you do not have affected product, check the box, I do not have affected product. d. Complete the attached Acknowledgement Form and return to [email protected] or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. A replacement order will also be placed for the quantity noted on the form. 2. Distributors a. If you do have the affected product listed in Table 1, remove the product from further distribution. b. Complete the attached form. If you do not have affected product, check the box, I do not have affected product. c. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. d. Complete the attached Acknowledgement Form and return to [email protected] or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. Please check your customer traceability records for shipments of above catalog numbers. g. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. h. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will co
Recall details
- Recall number
- Z-2224-2021
- Status
- Terminated
- Initiated by the company
- Jun 1, 2021
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 906 units
- Product code
- HBO
- Distribution
- US Nationwide Distribution - Foreign Distribution: Hong Kong
Product description
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Code information (models, lots, serial numbers)
Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CODMAN® 201037Integra Lifesciences Production Corporation · CLIP, SCALP1 recall4 reports
Product lines
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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