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.
Reported: August 3, 2016 Initiated: July 1, 2016 #Z-2296-2016
Product Description
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.
Reason for Recall
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 27 units
- Distribution
- Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Integra LifeSciences Corp.. Units affected: 27 units.
Why was this product recalled? ▼
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Moderate. Recall number: Z-2296-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11