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U.S. Department of Health and Human Services

Class 2 Device Recall Black Widow Buttress Plate and Screw

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  Class 2 Device Recall Black Widow Buttress Plate and Screw see related information
Date Initiated by Firm November 22, 2016
Date Posted December 22, 2016
Recall Status1 Terminated 3 on July 31, 2017
Recall Number Z-0887-2017
Recall Event ID 75869
510(K)Number K081770  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030
The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Code Information Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R; Part Number TBS025 Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030 Lot Number 08218, WT011711B, WT071014A
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information Contact Bryan Brosseau
404-610-7215
Manufacturer Reason
for Recall		 There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
FDA Determined
Cause 2		 Process change control
Action Amendia sent an Urgent Medical Device Recall letter dated November 22, 2016, to all affected consignees.. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. Customers with questions should call 1-855-755-3329. For questions regarding this recall call 404-610-7215.
Quantity in Commerce 96 units
Distribution Nationwide Distribution to IN, LA, and TX
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 = KWQ and Original Applicant = OMNI SURGICAL, L.P.
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