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.
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 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.
- 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
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.
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