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Trilogy® 6200-62-21

by Zimmer, Inc.

Ref 00-6200-062-21

Trilogy® 6200-62-21 (00-6200-062-21) is a device classified as Class III in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI B-00889024118232), cleared under FDA 510(k) K934765 on 29 Apr 1994 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00889024118232), active as of 7 Nov 2026. 14 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

16 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K934765

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024118232 Basic UDI-DI 00889024118232UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024118232 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK934765 Date29 Apr 1994IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024118232 registered 1 Nov 2026 Active
  • FDA 510(k) K934765 decided 29 Apr 1994 Active
  • FDA GUDID UDI-DI 00889024118232 listed 24 Sep 2015 Listed

Recalls

16 recalls · FDA

    • Terminated Z-1684-2016 FDA Class II initiated 4 May 2016

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

  • 4 recalls, same reason

    • Terminated Z-1161-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1115-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1145-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1123-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    • Terminated Z-0875-2015 FDA Class II initiated 4 Dec 2014

    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

    • Terminated Z-0824-2015 FDA Class II initiated 21 Nov 2014

    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. .

    • Terminated Z-2032-2014 FDA Class II initiated 12 Jun 2014 on shared 510(k) K934765

    Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

    • Terminated Z-1024-2014 FDA Class II initiated 11 Oct 2013

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

  • 5 recalls, same reason

    • Terminated Z-0769-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0772-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0771-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0773-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0775-2013 FDA Class II initiated 14 Sep 2012

    Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.

    • Terminated Z-0620-2008 FDA Unclassified (pre-2012) initiated 19 Oct 2007

    Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

    • Terminated Z-1344-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006 on shared 510(k) K934765

    Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

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

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-2032-2014
  2. Recall initiated FDA recalls Z-0824-2015
  3. Recall initiated FDA recalls Z-0875-2015
  4. Listed FDA GUDID 00889024118232
  5. Recall initiated FDA recalls Z-1161-2016
  6. Recall initiated FDA recalls Z-1115-2016
  7. Recall initiated FDA recalls Z-1145-2016
  8. Recall initiated FDA recalls Z-1123-2016
  9. Recall initiated FDA recalls Z-1684-2016
  10. Registered EUDAMED B-00889024118232

9 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Trilogy®
Generic name
Acetabular shell
Device name
HP Trilogy/TM Mod Trilogy Acetabular Implant Shells
Model / Ref / Catalog
00-6200-062-21, 6200-62-21
Primary DI / UDI-DI
00889024118232
Basic UDI-DI
B-00889024118232
510(k) Number
FDA product code
LPH
EMDN code
P090803010201 Primary implant uncemented metal acetabular cups
GMDN term
Acetabular shell
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3358
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 62 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-6200-062-21
GUDID
6200-62-21
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Acetabular shell

Cleared under the same submission (K934765)

and 8 more cleared under K934765

Similar devices in this category

Other devices filed under PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)