Smith & Nephew Recalls Healicoil Absorbable Suture Anchors for Seal Defects
Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
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 2/5 (Moderate).
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 the HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture Anchor (Product Number: 72203801). The recall is due to improper or incomplete seals on the product packaging pouch, which may result in a breach of the sterile barrier surrounding the device.
The affected products were distributed nationwide and in numerous foreign countries, including the United States, Canada, Australia, and various European and Asian nations. The recall covers specific batch numbers, including 2013918, 2016156, and 2017774, among others.
Consumers and healthcare providers should check their inventory for the specific product number and batch numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to their instructions.
The recalled product
- Product
- HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
- Manufacturer
- Smith & Nephew, Inc.
- 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.
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