Recall Z-1527-2016— Corin USA Limited

Name: FDA recall Z-1527-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-29

Class II · Terminated

Class II FDA medical device recall by Corin USA Limited, initiated 2016-01-29, terminated 2019-12-16. It names one FDA 510(k) clearance: K123705. Product: Trinity Acetabular Shell Product Usage: Total Hip Replacement.. Reason: Potential for abrasion of the sterile barrier pouches of the new packaging system..

Recalling firm: Corin USA Limited
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Terminated: 2019-12-16
Firm location: Tampa, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K123705 — TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLSCorin USA·cleared 2013-02-12

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

Trinity Acetabular Shell Product Usage: Total Hip Replacement.

Reason for recall

Potential for abrasion of the sterile barrier pouches of the new packaging system.

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