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.
FDA Recall Z-0109-2015 · Posted 2014-10-22
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Recalling FirmSignal Medical Corporation
Recall StatusTerminated
Product CodeLPH
Date Initiated2014-09-23
Date Terminated2015-01-20
Product Quantity12 devices
Reason for Recall
Incorrect dimension on four liners was detected
Firm Action
Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.
Root Cause
Process design
Distribution Pattern
US Distribution in MO only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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