DePuy Mitek Screw and Washer Depth Gauge Recalled for Design Offset
DePuy Mitek is recalling 401 Mitek Screw and Washer Depth Gauges because a design offset causes readings to be approximately 3.2mm shorter than the actual bone hole length.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with a design defect that affects measurement accuracy, representing a risk of harm where injury has not yet been reported.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 401 units of the Mitek Screw and Washer Depth Gauge, Product Code 219024. The recall is due to a design offset in the device that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
The affected products were distributed nationwide in the United States to the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed to foreign countries including Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, and the UK.
The agency has classified this recall as Class II. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- Mitek Screw and Washer Depth Gauge, Product Code 219024
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Affected units
- 401
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 10886705005390
Distribution
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