Z-0906-2022Class II

Integra Universal Flexible Arm part number REF 1362275

Name: Z-0906-2022 Integra Universal Flexible Arm part number REF 1362275
Creator: Integra LifeSciences Corp.
Published: 2022-02-28
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2022-02-28 / Open, Classified / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of Integra Universal Flexible Arm part number REF 1362275 on 2022-02-28. FDA classified it as Class II and gives the reason as "Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0906-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-28
Posted: 2022-04-11
Recalling firm: Integra LifeSciences Corporation
Product: Integra Universal Flexible Arm part number REF 1362275
Product code: FXG Specula Accessories
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.
Root cause tag: design
FDA root cause: Device Design
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: [email protected]
Quantity in commerce: 54
Distribution: US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
Product codes and lots: UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0906-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0906-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-11

Product code FXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)