REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
This recall is currently active, issued October 12, 2023.
- Recall Initiated
- August 22, 2023
- Posted
- October 12, 2023
- Recall Number
- Z-0098-2024
- Quantity
- 70
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9
Root Cause
Mixed-up of materials/components
Action Taken
On 8/22/23, recall notices were emailed to agents and registration holders who were asked to do the following: Contact Customer Service at 1-800-456-8696 to assist with return and replacement. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. Complete and return the acknowledgement and response form. If you have questions, please email productsafety@enovis.com