Summary
The FDA issued a Class II for META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 by Smith & Nephew, Inc.. Reason: Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, .
Details
Source
Device Recall
External ID
Z-1806-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
Product Description
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Lot/Code Info: UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Quantity Affected: 75
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-18
Company
Memphis, TN
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 147 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-1806-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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