The Recall Desk
SevereFDA (Devices)·Z-2387-2016·Announced 2016-08-17

Integra External Fixation System Slotted Post Recall for Breakage During Use

Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they 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 defect (breakage) in a medical device used during surgery, which aligns with the rubric criteria for 'Severe' severity involving significant injury or structural defects.

Plain-English summary

Integra LifeSciences Corp. is recalling 111 units of the Integra External Fixation System Slotted Post, including both Small (Catalogue #12224228) and Large (Catalogue #12224229) sizes. The affected lots are QJ0139, QJ0148, QJ0140, QJ0149, and QJ0287.

The recall was initiated after an investigation of reported complaints verified that the Universal Wire Fixation Bolts on the Slotted Post broke during use at the surgical site. This defect presents a risk of harm to patients during surgical procedures.

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 products should contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Orthopedic / External Fixation
Hazard
Affected units
111

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 (5)

  • Lot # QJ0139
  • QJ0148
  • QJ0140
  • QJ0149
  • QJ0287

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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