Z-1528-2016 Class II Terminated
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
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.