Smith & Nephew Inc.: Device Recall

Recall #Z-3096-2024 · 08/12/2024

Class II: Risk

Recall Details

Recall Number: Z-3096-2024
Classification: Class II
Product Type: Device
Recalling Firm: Smith & Nephew Inc.
Status: Ongoing
Date Initiated: 08/12/2024
Location: Andover, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US: 6305 units; OUS : 160 units

Reason for Recall

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

Product Description

ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).

Other Recalls by Smith & Nephew Inc.

Class II: Risk 11/24/2025

Removal of affected lot of screws due to labeling error.
Class II: Risk 03/18/2025

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Class II: Risk 10/29/2024

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Class II: Risk 10/15/2024

The Bipolar assembly contains an oversized Retainer Ring.
Class II: Risk 10/02/2024

Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

View all recalls by Smith & Nephew Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.