Smith & Nephew Recalls Healicoil Suture Anchors Due to Packaging Seal Issues
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a breach of the sterile barrier could lead to infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling 263,874 units of HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK Absorbable Suture Anchors (Product Number: 72203705). 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 to numerous foreign countries.
Consumers and healthcare providers should stop using the affected suture anchors and contact Smith & Nephew for further instructions.
The recalled product
- Product
- HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Surgical Suture
- 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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