Home / Recalls / Corin USA Limited / Z-1527-2016

Z-1527-2016 Class II Terminated

Recalled by Corin USA Limited — Tampa, FL

Recall Details

Product Type
Devices
Report Date
May 4, 2016
Initiation Date
January 29, 2016
Termination Date
December 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
629 devices in total

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.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.

Code Information

Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:

Other recalls by Corin USA Limited

  • Z-1526-2016 Class II — Trinity Acetabular System Product Usage - Total Hip Replacement. (January 29, 2016)
  • Z-1528-2016 Class II — Trinity Acetabular Shell Product Usage Total Hip Replacement. (January 29, 2016)