TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip i
Summary
The FDA issued a Class II for TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemen by Corin Ltd. Reason: Some of the devices did not pass fatigue testing..
Details
Source
Device Recall
External ID
Z-1667-2022
Action Date
2022-09-07
Status
Terminated
Category
device
Product Description
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Lot/Code Info: Model #588.3800, Lot #494754; UDI 05055343871065
Quantity Affected: 1
Reason for Recall
Some of the devices did not pass fatigue testing.
Distribution
Distribution was made to NJ. There was no military/government distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-12
Company
Cirencester
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Corin Ltd has 18 FDA actions in our database, including 17 recalls and 1 clearance.
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 (Corin Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Corin Ltd have FDA actions?
Corin Ltd has 18 FDA actions in our database, including 17 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1667-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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