Recall Z-0109-2015— Signal Medical Corporation

Name: FDA recall Z-0109-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-23

Class II · Terminated

Class II FDA medical device recall by Signal Medical Corporation, initiated 2014-09-23, terminated 2015-01-20. It names one FDA 510(k) clearance: K955271. 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.. Reason: Incorrect dimension on four liners was detected.

Recalling firm: Signal Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-09-23
Terminated: 2015-01-20
Firm location: Marysville, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K955271 — MICRO-SEAL ACETABULAR SYSTEMWhiteside Instruments·cleared 1996-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Incorrect dimension on four liners was detected

Data sourced from openFDA. This site is unofficial and independent of the FDA.