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U.S. Department of Health and Human Services

Class 2 Device Recall Mitek Screw and Washer Depth Gauge

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 Class 2 Device Recall Mitek Screw and Washer Depth Gaugesee related information
Date Initiated by FirmAugust 30, 2018
Create DateOctober 23, 2018
Recall Status1 Terminated 3 on June 05, 2020
Recall NumberZ-0208-2019
Recall Event ID 81059
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductMitek Screw and Washer Depth Gauge, Product Code 219024
Code Information UDI: 10886705005390; Lot Numbers: 0005178 1103107 0009101 1105132 0009181 1112106 0102157 1201104 0103045 950229 0205355 961232 0207451 970198 0208597 971229 0301615 980585 0302184 9809121 0303337 990765 0311333 C000007655 0311389 C000012527 0512552 C000020182 0605571 1000196842 0612501 1000415749 0707512 1000431580 0710501 1000661713 0801536 1001119996 0809117 1002144 0905130 1006113 0912100 1008120 1000064514 1103103
FEI Number 1221934
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information ContactChristine Corbett
636-636-0211
Manufacturer Reason
for Recall		The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Recall Notification letters were sent to customers on 8/30/18. Updated Urgent Medical Device Recall notification letters were sent to customers on 9/18/18
Quantity in Commerce401
DistributionUS nationwide in 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, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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