Zimmer Manufacturing B.V.: Medical Device Recall in 2014 - (Recall #: Z-0875-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of 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.

Product Classification:

Class II

Date Initiated: December 4, 2014

Date Posted: December 31, 2014

Recall Number: Z-0875-2015

Event ID: 69814

Reason for Recall:

Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which

Status: Terminated

Product Quantity: 68 units

Code Information:

Item No. 00-6200-054-20; Lot 62714305

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated