The Recall Desk
HighFDA (Devices)·Z-0147-2021·Announced 2020-10-28

Smith & Nephew Recalls Raptormite Suture Anchors Due to Seal Defects

Smith & Nephew is recalling Raptormite suture anchors because improper packaging seals may breach the sterile barrier.

What this means for you

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 the source text does not report any specific injuries or illnesses.

Plain-English summary

Smith & Nephew, Inc. is recalling the RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor (Product Number: 72201805). The recall involves 263,874 units distributed nationwide and to numerous foreign countries.

The recall was initiated because the product packaging may have an improper or incomplete seal on the pouch surrounding the sterile product. This defect may result in a breach of the sterile barrier created by the pouch.

Affected batch numbers include 2025354, 2031116, 2040066, 2040702, 2042557, 2049638, 2053749, and 2055239. Healthcare providers and consumers should check their inventory for these specific product and batch numbers.

The recalled product

Product
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
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 →