Recall Z-0906-2022— Integra LifeSciences Corp.
Class II · Ongoing
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2022-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Integra Universal Flexible Arm part number REF 1362275. Reason: Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-28
- Firm location
- Princeton, NJ, United States
Product description
Integra Universal Flexible Arm part number REF 1362275
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.