FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Integra Universal Flexible Arm part number REF 1362275
- Recall number
- Z-0906-2022
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Integra Universal Flexible Arm part number REF 1362275
- Status
- Open, Classified
- Initiated
- 2022-02-28
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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: custsvcnj@integralife.com
- Quantity
- 54
- Distribution
- US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
- Lot, serial or model codes
- UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FXG
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28