Trinity Acetabular Shell Product Usage Total Hip recall: Sterility Concern
Trinity Acetabular Shell Product Usage Total Hip Replacement.
Why was Trinity Acetabular Shell Product Usage Total Hip recalled?
Potential for abrasion of the sterile barrier pouches of the new packaging system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Trinity Acetabular Shell Product Usage Total Hip Replacement.
- Recalling firm
- Corin USA Limited
- 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.
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)