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Recall Observatory FDA recall evidence

Device product

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

Z-0326-2025

October 15, 2024

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 95568
Status
Ongoing
Classification
Class II
Quantity
21 devices
Official record key
device-enforcement:Z-0326-2025

Official wording

Reason: The Bipolar assembly contains an oversized Retainer Ring.

Code information: Batch W2401399, UDI-DI 03596010494375.

Distribution pattern: International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Bipolar assembly contains an oversized Retainer Ring.