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Continuum® Trabecular Metal™ 00-8757-068-01

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024151611 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2519-2023 FDA Class II initiated 26 Jul 2023

    The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

    • Terminated Z-0094-2015 FDA Class II initiated 1 Oct 2014

    The affected products are missing polar boss threads.

  • 2 recalls, same reason

    • Terminated Z-0071-2011 FDA Unclassified (pre-2012) initiated 19 Mar 2010 on shared 510(k) K091508
    • Terminated Z-0072-2011 FDA Unclassified (pre-2012) initiated 19 Mar 2010 on shared 510(k) K091508

    The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Continuum® Trabecular Metal™
Generic Name
Acetabular shell
Model / Ref / Catalog
00-8757-068-01
Primary DI / UDI-DI
00889024151611
510(k) Number
FDA Product Code
LZO, LPH, JDI
GMDN Term
Acetabular shell
Device Class
Class II
Regulation Number
888.3353, 888.3358, 888.3350
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 68 Millimeter

Related devices

Category: Acetabular shell

Cleared under the same submission (K091508)

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Cleared under the same submission (K151448)

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Cleared under the same submission (K200823)

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Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No