Skip to content

ROTATION MEDICAL TENDON STAPLES (8) (broad… recallZ-3096-2024 · Smith & Nephew Inc. · initiated Aug 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Packaging

What the company is doing

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 [email protected]. 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 [email protected]. 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 [email protected]

Recall details

Recall number
Z-3096-2024
Status
Open, Classified
Initiated by the company
Aug 12, 2024
Posted by the FDA
Sep 10, 2024
Recalling firm
Smith & Nephew Inc.
Quantity
US: 6305 units; OUS : 160 units
Product code
GDW
FDA submissions
K131637
Distribution
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).

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00854501006067 Batch Number 51180055 51180056 51180057 51180058 51180059 51180060 51180061 51180062 51180063 51180064 51180065 51184280 51184281 51184282 51184283 51184284 51184285 51184286 51184287 51184288 51184289 51184290 51185286 51185287 51185288 51185289 Batch Number 51185290 51185291 51185292 51185293 51185294 51185295 51185296 51189247 51189249 51189250 51189251 51189252 51189254 51189255 51189256 51189257 51189258 51189259 51193811 51193816 51193818 51193820

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page