SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Summary
The FDA issued a Class II for SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 by Synthes (USA) Products LLC. Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of th.
Details
Source
Device Recall
External ID
Z-0099-2023
Action Date
2022-10-26
Status
Ongoing
Category
device
Product Description
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Lot/Code Info: UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Quantity Affected: 94 US; 30 OUS
Reason for Recall
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-27
Company
West Chester, PA
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 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Synthes (USA) Products LLC has 26 FDA actions in our database, including 24 recalls and 2 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 (Synthes (USA) Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Synthes (USA) Products LLC have FDA actions?
Synthes (USA) Products LLC has 26 FDA actions in our database, including 24 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0099-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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