ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pr
Summary
The FDA issued a Class II for ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of by Smith & Nephew Inc.. Reason: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product.
Details
Source
Device Recall
External ID
Z-3096-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
Lot/Code Info: 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
Quantity Affected: 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
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).
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-12
Company
Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew Inc. has 78 FDA actions in our database, including 34 recalls and 44 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smith & Nephew Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew Inc. have FDA actions?
Smith & Nephew Inc. has 78 FDA actions in our database, including 34 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3096-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29