Smith & Nephew Inc.: Device Recall

Recall Details

Recall Number

Z-3097-2024

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

2961 units (OUS)

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) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201

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. →