Z-0824-2015Class II

Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and...

Name: Z-0824-2015 Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and...
Creator: Zimmer Manufacturing B.V.
Published: 2014-11-21
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2014-11-21 / Terminated / root cause: manufacturing process

FDA source

Zimmer Manufacturing B.V. began a recall of Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for... on 2014-11-21. FDA classified it as Class II and gives the reason as "Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0824-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Posted: 2014-12-17
Terminated: 2015-08-10
Recalling firm: Zimmer Manufacturing B.V.
Product: Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. 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: Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Zimmer sent an Urgent Medical Device Recall letter dated November 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. Customers were advised to quarantine any affected product and notify their Zimmer sales representative who will remove the recalled product from their facility. For patients who previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
Quantity in commerce: 6,377
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada Australia Brazil Chile China Colombia Japan Malaysia Singapore South Korea Taiwan Albania Austria Belgium Bulgaria Canary Islands Czech Republic Denmark Egypt Finland France Germany Greece Hungary Ireland Italy Netherlands Norway Poland Portugal Russia Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey and United Kingdom.
Product codes and lots: Item Number Lot Number 00-6250-065-35 62748089 00-6250-065-35 62754329 00-6250-065-35 62793494 00-6250-065-35 62793495 00-6250-065-35 62793501 00-6250-065-35 62793502 00-6250-065-35 62793503 00-6250-065-35 62813612 00-6250-065-35 62813613 00-6250-065-25 62784617 00-6250-065-25 62784618 2 00-6250-065-25 62784619 00-6250-065-25 62784621 00-6250-065-25 62784622 00-6250-065-25 62818701 00-6250-065-25 62818702 00-6250-065-25 62818703 00-6250-065-25 62818707 00-6250-065-25 62818709 00-6250-065-25 62818710 00-6250-065-25 62825611 00-6250-065-25 62836984

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0824-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0824-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

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)