Medtronic Sofamor Danek USA Inc: Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2.

Hazard

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Details from the source

Reason for recall: Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur. Distribution: Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom. Quantity: 275,260 units Lot/code info: IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. GTIN (Lot Numbers): 00763000246693 (0835083W, 0836192W, 0837725W, 0837727W, 0839577W, 0839579W, 0839591W, 0839593W, 0839595W, 0841459W, 0842257W, 0842767W, 0842769W, 0845001W, 0845003W, 0846533W, 0849546W, 0849548W, 0849998W, 0854451W, 0856696W, 0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0873202W, 0874502W, 0874504W, 0877435W, 0878670W, 0879342W, 0879887W, 0881316W, 0885958W, 0885960W, 0886068W, 0886070W, 0887342W, 0888799W, 0889934W, 0889936W, 0891419W, 0891951W, 0893270W, 0893332W, 0894905W, 0896952W, 0896954W, 0897308W, 0900773W, 0900970W, 0901192W, 0902362W, 0903362W, 0904350W, 0906154W, 0907656W, 0908818W, 0908820W, 0910150W, 0910202W, 0914572W, 0914574W, 0914576W, 0914578W, 0914580W, 0917478W, 0917480W, 0917662W, 0918071W, 0918073W, 0918075W, 0918077W, 0918858W, 0918860W, 0918862W, 0918864W, 0918866W, 0918886W, 0918888W, 0922033W, 0924471W, 0925397W, 0926139W, 0926361W, 0927266W, 0931914W, 0931916W, 0933069W, 0933071W, 0933073W, 0933075W, 0934823W, 0934825W, 0934827W, 0934998W, 0935000W, 0936452W, 0936454W, 0936456W, 0936458W, 0937870W, 0937872W, 0939113W, 0939115W, 0939324W, 0939326W, 0941080W, 0941364W, 0941366W, 0941912W, 0941914W, 0942912W, 0943255W, 0943257W, 0943953W, 0943955W, 0943957W, 0945701W, 0945946W, 0945948W, 0945950W, 0950146W, 0950148W, 0950150W, 0951512W, 0951514W, 0951516W, 0952750W, 0952752W, 0954062W, 0954064W, 0954430W, 0955352W, 095

UPC codes

00763000246693, 00763000529567, 00763000246709, 00763000529574, 00763000246723, 00763000529581, 00763000246730, 00763000529598, 00763000246754, 00763000529604, 00763000246761, 00763000529611, 00763000246785, 00763000868963, 00763000246792, 00763000529628, 00763000246815

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.