The Recall Desk
ModerateFDA (Devices)·Z-0152-2021·Announced 2020-10-28

Smith & Nephew Recalls OSTEORAPTOR 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 OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE Absorbable Suture Anchors (Product Number: 72201995). The recall is due to improper or incomplete seals on the pouch surrounding the sterile product, which may result in a breach of the sterile barrier.

The affected products were distributed nationwide and in numerous foreign countries, including the United States, Canada, and various locations in Europe, Asia, and South America. The source text lists specific batch numbers associated with this recall.

Consumers and healthcare providers should stop using the affected suture anchors and contact Smith & Nephew for further instructions on how to return or dispose of the product.

The recalled product

Product
OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

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 →