Z-0098-2024 Class II Ongoing
FDA device recall Z-0098-2024 was initiated by Encore Medical, LP on Aug 22, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 70.
Recall details
- Product Type
- Devices
- Report Date
- Oct 18, 2023
- Initiation Date
- Aug 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70
Product description
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
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 pattern
US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Code information
UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0098-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026