Integra External Fixation System Wire Fixation Bolts Recalled for Breakage
Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural failure of a medical device during use, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra External Fixation System Universal Wire Fixation Bolts, specifically the 17.5 mm (Catalogue #12224218) and 23 mm (Catalogue #12224219) models. The recall involves 495 units from Lot # GT0420 and GT0419.
The recall was initiated after an investigation of reported complaints verified that the Slotted Post on the Universal Wire Fixation Bolts broke during use at the surgical site. The affected products were distributed in the United States to the states of Florida, Virginia, Oklahoma, Colorado, the District of Columbia, and Indiana.
Healthcare providers and patients who have used these specific devices should contact their healthcare provider or the recalling firm for further instructions regarding the recall.
The recalled product
- Product
- Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 495
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # GT0420 and GT0419
Distribution
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- HighIntegra External Fixation System Rocker Bottom Recall for Loose Silicone Insert
FDA (Devices) · 2016-08-03
- HighIntegra Universal Flexible Arm Recall: Internal Cable May Break
FDA (Devices) · 2022-04-20
- HighZimmer Biomet Recalls Connecting Bolts Due to Material Error
FDA (Devices) · 2018-08-29
- HighOrthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction
FDA (Devices) · 2023-02-22
- SevereIntegra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
FDA (Devices) · 2013-07-17
- HighApplied Medical Recalls Wilson Implantation System Due to Sterilization Breach
FDA (Devices) · 2016-05-11