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Class 2 Device Recall T7 Driver Solid AO |
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Date Initiated by Firm |
March 28, 2019 |
Create Date |
May 09, 2019 |
Recall Status1 |
Terminated 3 on June 02, 2020 |
Recall Number |
Z-1303-2019 |
Recall Event ID |
82640 |
510(K)Number |
K142658
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Product Classification |
Screw, fixation, bone - Product Code HWC
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Product |
T7 Driver Solid AO (Part Number 110018541)
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.
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Code Information |
Lot Numbers: 13421A 13811A 14042B 14048B 14140A 14194B 14343A 14392A 14393A 14394A 14518A 14601A 14827B 14895C 15015B 15167B 15257A 15392A |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact |
411 Technical Services 574-371-3071
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Manufacturer Reason for Recall |
There is a potential of fracture, bending or shearing of the driver.
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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 |
1924 |
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
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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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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = BIOMET MANUFACTURING CORP.
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