FDA-Device2023-10-18Class II
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Encore Medical, LP
Hazard
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.
Sold states
US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Affected count
70
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0098-2024Don't want to check this manually?
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