Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Summary
The FDA issued a Class II for Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-ste by Wright Medical Technology, Inc.. Reason: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereb.
Details
Source
Device Recall
External ID
Z-2105-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Lot/Code Info: Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
Quantity Affected: 106 devices
Reason for Recall
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Distribution
There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-13
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 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wright Medical Technology, Inc. has 21 FDA actions in our database, including 21 recalls.
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 (Wright Medical Technology, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wright Medical Technology, Inc. have FDA actions?
Wright Medical Technology, Inc. has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2105-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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