The Recall Desk
SevereFDA (Devices)·Z-2386-2016·Announced 2016-08-17

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Orthopedic Fixation
Hazard
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

Distributed in 6 states:

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.

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Same hazard · structural failure

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