Z-3097-2024Class II

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft...

Name: Z-3097-2024 ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft...
Creator: Smith & Nephew Inc.
Published: 2024-08-12
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-08-12 / Open, Classified / root cause: packaging

FDA source

Smith & Nephew Inc. began a recall of ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201 on 2024-08-12. FDA classified it as Class II and gives the reason as "Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3097-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-12
Posted: 2024-09-10
Recalling firm: Smith & Nephew, Inc.
Product: ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Product code: GDW Staple, Implantable
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
Root cause tag: packaging
FDA root cause: Packaging
Action: 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]
Quantity in commerce: 2961 units (OUS)
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3097-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3096-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10
Z-3097-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10

Product code GDW

K131637Class IIRotation Medical Soft Tissue Staple (Rmst Staple)Rotation Medical, Inc. / cleared 2013-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)