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Recall Observatory FDA recall evidence

Device product

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 thickness and width capabilities Part number: 00880000010

Z-0069-2024

September 05, 2023

Class II

Product summary

Firm
Zimmer Surgical Inc
Event
Event 93021
Status
Ongoing
Classification
Class II
Quantity
11,985 boxes (119,850 blades)
Official record key
device-enforcement:Z-0069-2024

Official wording

Reason: 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

Code information: 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(10)65630969 (01)00889024380318(17)280212(10)65647382 (01)00889024380318(17)280213(10)65648460 (01)00889024380318(17)280214(10)65709066 (01)00889024380318(17)280219(10)65925347 (01)00889024380318(17)280220(10)65925348 (01)00889024380318(17)280221(10)65935737 (01)00889024380318(17)280223(10)65935738 (01)00889024380318(17)280319(10)65952857 (01)00889024380318(17)280424(10)65952858 (01)00889024380318(17)280430(10)65972711 (01)00889024380318(17)280503(10)65972712 (01)00889024380318(17)280507(10)65988623 (01)00889024380318(17)280426(10)65952862 (01)00889024380318(17)280509(10)65988624 (01)00889024380318(17)280514(10)65989036 (01)00889024380318(17)280516(10)65989037 (01)00889024380318(17)280520(10)66000975 (01)00889024380318(17)280523(10)66000976 (01)00889024380318(17)280528(10)66002852 (01)00889024380318(17)280530(10)65952860 (01)00889024380318(17)280610(10)66002853 (01)00889024380318(17)280613(10)66014333 (01)00889024380318(17)280617(10)66014332 (01)00889024380318(17)280624(10)66038885 (01)00889024380318(17)280628(10)66172214 (01)00889024380318(17)280710(10)66049031 (01)00889024380318(17)280724(10)66078057 (01)00889024380318(17)280719(10)66049032 Lot Numbers: 65599469 65620875 65621233 65630969 65647382 65648460 65709066 65925347 65925348 65935737 65935738 65952857 65952858 65972711 65972712 65988623 65952862 65988624 65989036 65989037 66000975 66000976 66002852 65952860 66002853 66014333 66014332 66038885 66172214 66049031 66078057 66049032

Distribution pattern: US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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