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U.S. Department of Health and Human Services

Class 2 Device Recall Microseal Augmented (20 degree) Liner

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  Class 2 Device Recall Microseal Augmented (20 degree) Liner see related information
Date Initiated by Firm September 23, 2014
Date Posted October 22, 2014
Recall Status1 Terminated 3 on January 20, 2015
Recall Number Z-0109-2015
Recall Event ID 69418
510(K)Number K955271  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20.

Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
Code Information Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085  Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099  Catalog # WB-1-1110, Size: 36x50x20, Serial #: B13105  Catalog # WB-1-1110, Size: 36x50x20, Serial # B13106
Recalling Firm/
Manufacturer		 Signal Medical Corporation
400 Pyramid Dr
Marysville MI 48040-2463
For Additional Information Contact Melinda Finnie
810-364-7070
Manufacturer Reason
for Recall		 Incorrect dimension on four liners was detected
FDA Determined
Cause 2		 Process design
Action Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.
Quantity in Commerce 12 devices
Distribution US Distribution in MO only.
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 = LPH and Original Applicant = WHITESIDE INSTRUMENTS
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