Recall Z-1528-2016
Corin USA Limited · initiated January 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Trinity Acetabular Shell Product Usage Total Hip Replacement.
Codes / lots: No Hole Shell 048mm Taper Size 2, Lot Codes: 322986, 323743, 320026, 322977, 323744; No Hole Shell 052mm Taper Size 3, Lot Codes: 322396, 322971, 322403, 322984, 322985, 323750.
Reason for recall
Potential for abrasion of the sterile barrier pouches of the new packaging system.
FDA-determined cause: Packaging process control
Action taken
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 Contact information as Corin LTD Compliance Director at +44 (0) 1285 649190 Monday thru Friday 8:30am to 5:00pm UK Time
Details
- Recall number
- Z-1528-2016
- Initiated
- January 29, 2016
- Terminated
- December 16, 2019
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- 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.
- Recalling firm
- Corin USA Limited, Tampa, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1526-2016 Class II | Trinity Acetabular System Product Usage - Total Hip Replacement.Potential for abrasion of the sterile barrier pouches of the new packaging system. | 01/29/2016Terminated |
| Z-1527-2016 Class II | Trinity Acetabular Shell Product Usage: Total Hip Replacement.Potential for abrasion of the sterile barrier pouches of the new packaging system. | 01/29/2016Terminated |