Zimmer Surgical Inc: Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thic

Hazard

Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area

Details from the source

Reason for recall: Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area Distribution: US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND Quantity: 11,985 boxes (119,850 blades) Lot/code info: FG (Blade) UDI: (01)00889024375895(17)280205(10)65599469 (01)00889024375895(17)280206(10)65620875 (01)00889024375895(17)280207(10)65621233 (01)00889024375895(17)280209(10)65630969 (01)00889024375895(17)280212(10)65647382 (01)00889024375895(17)280213(10)65648460 (01)00889024375895(17)280214(10)65709066 (01)00889024375895(17)280219(10)65925347 (01)00889024375895(17)280220(10)65925348 (01)00889024375895(17)280221(10)65935737 (01)00889024375895(17)280223(10)65935738 (01)00889024375895(17)280319(10)65952857 (01)00889024375895(17)280424(10)65952858 (01)00889024375895(17)280430(10)65972711 (01)00889024375895(17)280503(10)65972712 (01)00889024375895(17)280507(10)65988623 (01)00889024375895(17)280426(10)65952862 (01)00889024375895(17)280509(10)65988624 (01)00889024375895(17)280514(10)65989036 (01)00889024375895(17)280516(10)65989037 (01)00889024375895(17)280520(10)66000975 (01)00889024375895(17)280523(10)66000976 (01)00889024375895(17)280528(10)66002852 (01)00889024375895(17)280530(10)65952860 (01)00889024375895(17)280610(10)66002853 (01)00889024375895(17)280613(10)66014333 (01)00889024375895(17)280617(10)66014332 (01)00889024375895(17)280624(10)66038885 (01)00889024375895(17)280628(10)66172214 (01)00889024375895(17)280710(10)66049031 (01)00889024375895(17)280724(10)66078057 (01)00889024375895(17)280719(10)66049032 Sales Unit (Box) UDI (01)00889024380318(17)280205(10)65599469 (01)00889024380318(17)280206(10)65620875 (01)00889024380318(17)280207(10)65621233 (01)00889024380318(17)280209

UPC codes

00889024375895, 00889024380318

Source

Official record: FDA (Device enforcement) ↗

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