Integra Universal Flexible Arm part number REF 1362275 recallZ-0906-2022 · Integra LifeSciences Corp. · initiated Feb 28, 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 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
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
FDA root cause category: Device Design
What the company is doing
Urgent Voluntary Medical Device Recall Notice dated 02/28/2022 was sent via FexEx. Customers are instructed to remove the affected product from service, return it to Integra and complete and submit the attached acknowledgment form. Contact Customer Service with questions: Phone: 1-800-654-2873, Email: [email protected]
Recall details
- Recall number
- Z-0906-2022
- Status
- Open, Classified
- Initiated by the company
- Feb 28, 2022
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 54
- Product code
- FXG
- Distribution
- US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
Product description
Integra Universal Flexible Arm part number REF 1362275
Code information (models, lots, serial numbers)
UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Integra® 1362275Integra Lifesciences Production Corporation · SPECULA ACCESSORIES1 recall1 report
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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