RecallRadar

FDA Device recall Z-0906-2022

Integra Universal Flexible Arm part number REF 1362275

On 2022-04-20 the FDA classified a Class II recall of Integra Universal Flexible Arm part number REF 1362275 by Integra Lifesciences, citing excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0906-2022
ClassificationClass II
Statusongoing
Initiated2022-02-28
Published2022-04-20
Last updated2026-09-13 11:56 UTC
CompanyIntegra Lifesciences
DistributionUS

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.

Identifiers

code_infoUDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0906-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.