RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Summary
The FDA issued a Class II for RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical should by Encore Medical, LP. Reason: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver.
Details
Source
Device Recall
External ID
Z-0532-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Lot/Code Info: Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893
Quantity Affected: 146 units
Reason for Recall
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Distribution
U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-06
Company
Austin, TX
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 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Encore Medical, LP has 44 FDA actions in our database, including 44 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 (Encore Medical, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Encore Medical, LP have FDA actions?
Encore Medical, LP has 44 FDA actions in our database, including 44 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0532-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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