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Recall Issued for Zimmer Trabecular Metal Modular Acetabular System


Washington, DC: A Class 2 Recall has been issued for Zimmer Trabecular Metal Modular Acetabular System, a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty.

The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.

Lot # 61132698, may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell.

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Published on Oct-3-11

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READER COMMENTS

Posted by
Kathleen Curran Barcomb
on
I have both hips replaced.Both with Zimmer products. Both have failed. Right has been revised and left needs to be.

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