REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
FDA Recall Z-0098-2024 · Posted 2023-10-12
Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2023-08-22
Product Quantity70
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.
Firm Action
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 [email protected]
Root Cause
Mixed-up of materials/components
Distribution Pattern
US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.