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U.S. Department of Health and Human Services

Class 2 Device Recall T7 Driver Cannulated AO

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  Class 2 Device Recall T7 Driver Cannulated AO see related information
Date Initiated by Firm March 28, 2019
Create Date May 09, 2019
Recall Status1 Terminated 3 on June 02, 2020
Recall Number Z-1302-2019
Recall Event ID 82640
510(K)Number K142658  
Product Classification Screw, fixation, bone - Product Code HWC
Product T7 Driver Cannulated AO (Part Number 110018531)

Product Usage:
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Code Information Lot Numbers: 13422A 13869A 13870A 14042A 14048A 14090A 14090B 14090C 14090D 14090E 14194A 14194C 14194E 14194F 14194G 14224A 14827A 14827C 14827D 14827E 14827F 14895A 14895B 15015A 15167A 15167C 15310A 15310B 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 There is a potential of fracture, bending or shearing of the driver.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Removal and Notice of Discontinuation notification letters dated 3/28/19 were sent to customers. The letter identified the affected product problem and actions to be taken. For questions or concerns call customer service at 574-371-307.
Quantity in Commerce 5885
Distribution Worldwide Distribution - US Nationwide in the states: AK, AL, AR, AZ, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC< SD< TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Canada, Costa Rica, Malaysia, Netherlands, and Singapore.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = BIOMET MANUFACTURING CORP.
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