The Recall Desk
ModerateFDA (Devices)·Z-0165-2021·Announced 2020-10-28

Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Smith & Nephew, Inc. is recalling 263,874 units of OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE Absorbable Suture Anchors (Product Number: 72203290). The recall is due to improper or incomplete seals on the product packaging.

The defect may result in a breach of the sterile barrier created by the pouch surrounding the sterile product. The affected units were distributed nationwide and in numerous foreign countries, including the United States, Canada, and various nations in Europe, Asia, and South America.

Healthcare providers and facilities should identify and stop using the affected suture anchors. Consumers are advised to contact their healthcare provider or the manufacturer for further instructions regarding the recall.

The recalled product

Product
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
Affected units
263,874

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 40 recalled by Smith & Nephew, Inc. 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 40 products in this recall →