smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Summary
The FDA issued a Class II for smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during by Smith & Nephew Orthopaedics Ltd. (Aurora). Reason: The nail head may become detached during surgery..
Details
Source
Device Recall
External ID
Z-2242-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Lot/Code Info: Lot/Batch Codes: 20LW15962, 20LW15963
Quantity Affected: 47 units
Reason for Recall
The nail head may become detached during surgery.
Distribution
Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-14
Company
Leamington Spa, N/A
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 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 Orthopaedics Ltd. (Aurora)) 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 Orthopaedics Ltd. (Aurora) have FDA actions?
This is the only FDA action we have on record for Smith & Nephew Orthopaedics Ltd. (Aurora) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2242-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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