Data Foundry

Medical device recalls 2014

Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy… — Class II medical device recall Z-0875-2015

Terminated recall by Zimmer Manufacturing B.V., reported 2014-12-31, distributed nationwide. Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not at

Recall numberZ-0875-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Manufacturing B.V., Mercedita, PR, United States
Recall initiated2014-12-04
Classified2014-12-24
Reported by FDA2014-12-31
Terminated2015-06-18
DistributedNationwide (US)
Countries outside the USDE, FR, GB, IR, RO, RS, SG, TW
Quantity68 units
Lot numbers62714305
Model numbers00-6200-054-20

Product

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.

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0875-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.