—#209678

Product

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K131637
Affected lot / code info: UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

Smith & Nephew issued Urgent Medical Device Recall Notice R-2024-06 on 8/12/24. Letter states reason for recall, health risk and action to take: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in Section A. 2. If you have no product to return: a. Please put an X in the appropriate box below. b. Complete Section B of the form, sign and send to FieldActions@smith-nephew.com. 3. If you have product to return: a. Please complete Section A - list the product part number, batches, and quantities that you are returning. b. Complete Section B of the form, sign and send to FieldActions@smith-nephew.com. c. Once the form is received by Smith+Nephew, you will be sent a Return Authorization (RA) number. d. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 76 South Meridian Avenue | Oklahoma City, OK 73107 If you have any questions or concerns regarding this recall please contact FieldActions@smithnephew.com

Recalling firm

Firm: Smith & Nephew Inc.
Address: 150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

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).

Timeline

Recall initiated: 2024-08-12
Posted by FDA: 2024-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.