Canary Medical, Inc.: Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Perso

Hazard

Due to labeling error. Product incorrectly labeled.

Details from the source

Reason for recall: Due to labeling error. Product incorrectly labeled. Distribution: US Distribution to IN only. Quantity: 106 Lot/code info: Lot Code: Model No: 43-5570-030-14UDI-DI (GTIN): 00860003118399 Lot Numbers: AJ327, AJ330, AJ592 Serial Numbers: Provided in Attachment Lot Numbers / CSE Serial Numbers / UDI code: AJ327 30939 (01)00860003118399(17)270228(21)030939 AJ327 30972 (01)00860003118399(17)270228(21)030972 AJ592 31048 (01)00860003118399(17)270228(21)031048 AJ592 31050 (01)00860003118399(17)270228(21)031050 AJ592 31053 (01)00860003118399(17)270228(21)031053 AJ592 31064 (01)00860003118399(17)270228(21)031064 AJ592 31083 (01)00860003118399(17)270228(21)031083 AJ592 31088 (01)00860003118399(17)270228(21)031088 AJ592 31090 (01)00860003118399(17)270228(21)031090 AJ592 31093 (01)00860003118399(17)270228(21)031093 AJ592 31095 (01)00860003118399(17)270228(21)031095 AJ592 31096 (01)00860003118399(17)270228(21)031096 AJ592 31098 (01)00860003118399(17)270228(21)031098 AJ592 31102 (01)00860003118399(17)270228(21)031102 AJ592 31104 (01)00860003118399(17)270228(21)031104 AJ592 31120 (01)00860003118399(17)270228(21)031120 AJ592 31121 (01)00860003118399(17)270228(21)031121 AJ592 31129 (01)00860003118399(17)270228(21)031129 AJ592 31168 (01)00860003118399(17)270228(21)031168 AJ592 31277 (01)00860003118399(17)270228(21)031277 AJ592 31370 (01)00860003118399(17)270228(21)031370 AJ592 31412 (01)00860003118399(17)270228(21)031412 AJ592 31415 (01)00860003118399(17)270228(21)031415 AJ592 31429 (01)00860003118399(17)270228(21)031429 AJ592 31439 (01)00860003118399(17)270228(21)031439 AJ592 31449 (01)00860003118399(17)270228(21)

UPC codes

00860003118399

Source

Official record: FDA (Device enforcement) ↗

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