INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Summary
The FDA issued a Class II for INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DE by Smith & Nephew Orthopaedics GmbH. Reason: Right nails were anodized, marked, and labelled as left nails and vice versa.
Details
Source
Device Recall
External ID
Z-1133-2022
Action Date
2022-06-01
Status
Ongoing
Category
device
Product Description
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Lot/Code Info: Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989
Quantity Affected: 17 units
Reason for Recall
Right nails were anodized, marked, and labelled as left nails and vice versa
Distribution
Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-22
Company
Tuttlingen
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 139 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 GmbH) 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 GmbH have FDA actions?
This is the only FDA action we have on record for Smith & Nephew Orthopaedics GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1133-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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