Zimmer Manufacturing B.V.: 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.

Recall number

Z-0824-2015

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.

Status

Terminated

Initiated

2014-11-21

Posted

2014-12-17

Terminated

2015-08-10

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K934765"]

PMA numbers

not on file

Product code

LPH

Firm FEI

1000132037

Firm city

not on file

Firm state

not on file

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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