REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Summary
The FDA issued a Class II for REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF by Encore Medical, LP. Reason: Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in.
Details
Source
Device Recall
External ID
Z-0098-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Lot/Code Info: UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9
Quantity Affected: 70
Reason for Recall
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
Distribution
US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-22
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 179 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-0098-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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