Recall Z-1527-2016 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Corin USA Limited
Trinity Acetabular Shell Product Usage: Total Hip Replacement.
| Date | Jan 29, 2016 |
| Status | Terminated |
| Reason | Potential for abrasion of the sterile barrier pouches of the new packaging system. |
| Root cause | Packaging process control |
| Action | Corin sent an Urgent Medical Device Recall letter dated February 3, 2016. The letter identified the affected product, problem and actions to be taken. On January 29, 2016, Eight (8) of 11 distributors were spoken to during a Corin National Sales Meeting informing them of the recall. The 3 remaining distributors were notified by phone calls same date. Also, on February 2, 2016 Corin sent a Recall Letter to their Foreign consignee informating them of the recall of the Trinity Acetabular Shell and the actions to be take by the costumers including the return of the Customer Response Form and C |
| Quantity | 629 devices in total |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS Corin USA, Feb 12, 2013 |