Z-0875-2015Class II

Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either...

Name: Z-0875-2015 Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either...
Creator: Zimmer Manufacturing B.V.
Published: 2014-12-04
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2014-12-04 / Terminated

FDA source

Zimmer Manufacturing B.V. began a recall of Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature... on 2014-12-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0875-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Posted: 2014-12-24
Terminated: 2015-06-18
Recalling firm: Zimmer Manufacturing B.V.
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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
FDA root cause: Under Investigation by firm
Action: The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" memo dated 12/4/2014 to its customers. The memo described the product, problem and actions to be taken. The customers were instructed to locate all product from the listed lot and quarantine them immediately; carry out a physical count of all affected product in inventory; complete and return the Inventory Return Certification Form via email to: [email protected] on or before 12/12/2014; return the recalled product along with Inventory Return Certification Form on or before 12/12/2014; keep and maintain a copy for your records; and notify Zimmer of any hospitals that you have further distributed the affected product to and complete spreadsheet template provided. After reviewing this notification you have further questions or concerns, call the customer call center at 1-800-348-2759 between 8:00 am and 5:00 pm EST.
Quantity in commerce: 68 units
Distribution: Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.
Product codes and lots: Item No. 00-6200-054-20; Lot 62714305

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0875-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0875-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24

Product code LPH

K934765Class IITrilogy Acetabular SystemZimmer, Inc. / cleared 1994-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)