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Recall Observatory FDA recall evidence

Device product

Trinity Acetabular Shell Product Usage Total Hip Replacement.

Z-1528-2016

January 29, 2016

Class II

Product summary

Firm
Corin USA Limited
Event
Event 73205
Status
Terminated
Classification
Class II
Quantity
629 devices in total
Official record key
device-enforcement:Z-1528-2016

Official wording

Reason: Potential for abrasion of the sterile barrier pouches of the new packaging system.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for abrasion of the sterile barrier pouches of the new packaging system.