| | Class 2 Device Recall Universal Flexible Arm |  |
| Date Initiated by Firm | February 28, 2022 |
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| Create Date | April 11, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0906-2022 |
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| Recall Event ID |
89830 |
| Product Classification |
Specula accessories - Product Code FXG
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| Product | Integra Universal Flexible Arm part number REF 1362275 |
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| Code Information |
UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009 |
| FEI Number |
3003418325
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Recalling Firm/
Manufacturer |
Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
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| For Additional Information Contact |
609-275-0500 |
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Manufacturer Reason
for Recall | Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition. |
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FDA Determined
Cause 2 | Device Design |
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| Action | 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: custsvcnj@integralife.com |
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| Quantity in Commerce | 54 |
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| Distribution | US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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