The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2227-2013·Announced 2013-09-25

Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect (sterile barrier breach) poses a significant risk of harm such as infection.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling the OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black (Part Number: 72203291). This biodegradable suture anchor is subject to a Class II recall by the U.S. Food and Drug Administration.

The recall was initiated because pinholes were detected in a small number of primary pouches. These pinholes may constitute a breach of the sterile barrier, which could potentially compromise the sterility of the device.

The affected units were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for further instructions on return or replacement.

The recalled product

Product
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
Category
Medical Device — Surgical Suture Anchor
Hazard
Affected units
4,946

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 26 recalled by Smith & Nephew, Inc. Endoscopy Division 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 26 products in this recall →

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