Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting
Summary
The FDA issued a Class II for Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the derm by Zimmer Surgical Inc. 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 addit.
Details
Source
Device Recall
External ID
Z-0069-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
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
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(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
Quantity Affected: 11,985 boxes (119,850 blades)
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-05
Company
Dover, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer Surgical Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer Surgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer Surgical Inc have FDA actions?
Zimmer Surgical Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0069-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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