FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
- Recall number
- Z-2296-2016
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
- Status
- Terminated
- Initiated
- 2016-07-01
- Posted
- not on file
- Terminated
- 2016-12-16
- Reason
- The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
- Root cause
- Device Design
- Action
- All affected consignees were notified via an "Urgent: Voluntary Medical Device Recall" letter sent on 7/1/16. The letter identified the affected product as well as the reason for the recall. Customers were asked to check their traceability records for shipments of the affected product. If the affected parts are found, customers are to stop use and distribution. A copy of the letter should be provided to any customers that the product may have been distributed to. The attached "Acknowledgement and Return Form" should be completed and returned regardless if customers have affected product or not. Questions regarding the instructions should be directed to Customer Service at 1-800-654-2873.
- Quantity
- 27 units
- Distribution
- Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
- Lot, serial or model codes
- Lot # PN625.
- 510(k) numbers
- ["K140463"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- 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