The Recall Desk
HighFDA (Devices)·Z-0906-2022·Announced 2022-04-20

Integra Universal Flexible Arm Recall: Internal Cable May Break

Integra LifeSciences is recalling the Universal Flexible Arm (part number REF 1362275) because excess tightening force can break the internal cable at the tip, rendering the device unusable.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where malfunction during use could compromise critical procedures. Although no injuries have been reported, the internal cable breakage creates a functional failure hazard with potential for patient harm during medical application. FDA Class II applies to this device defect recall.

Plain-English summary

Integra LifeSciences Corp. is recalling the Universal Flexible Arm (part number REF 1362275). Approximately 54 units have been distributed nationwide across multiple U.S. states.

Excess force applied when tightening the flexible arm can cause the internal cable to break at the tip, resulting in an unusable device. The affected lot numbers are AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, and AC2009. The recalled units were distributed to facilities in Alabama, Arizona, Florida, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Oregon, Pennsylvania, and Texas.

The recalled product

Product
Integra Universal Flexible Arm part number REF 1362275
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Instrument
Hazard
  • cable-breakage
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • UDI#10381780074670
  • Lots: AC2109
  • AC2103
  • AC2106
  • AC2110
  • AC2101
  • AC2008
  • AC2009

Distribution

Distributed nationwide across the United States.

Related recalls

Same category