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ToggleLoc with Ziploop 909854

by Biomet Orthopedics, Inc.

Ref 909854

ToggleLoc with Ziploop 909854 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-00880304470361), cleared under FDA 510(k) K130033 on 1 Aug 2013 (2 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304470361), active as of 25 Oct 2026. 8 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130033

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00880304470361 Basic UDI-DI 00880304470361UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304470361 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130033 Date1 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00880304470361 registered 20 Oct 2026 Active
  • FDA 510(k) K130033 decided 1 Aug 2013 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00880304470361 listed 24 Oct 2015 Listed

Recalls

8 recalls · 1 ongoing · FDA

    • Ongoing Z-0212-2026 FDA Class II initiated 23 Sep 2025

    There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

    • Terminated Z-0818-2018 FDA Class II initiated 22 Aug 2017

    Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.

    • Terminated Z-1828-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

    • Terminated Z-1363-2015 FDA Class II initiated 26 Feb 2015

    The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.

  • 2 recalls, same reason

    • Terminated Z-1953-2010 FDA Unclassified (pre-2012) initiated 31 Mar 2010
    • Terminated Z-1952-2010 FDA Unclassified (pre-2012) initiated 31 Mar 2010

    The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.

  • 2 recalls, same reason

    • Terminated Z-0559-2010 FDA Unclassified (pre-2012) initiated 10 Nov 2009
    • Terminated Z-0560-2010 FDA Unclassified (pre-2012) initiated 10 Nov 2009

    Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-0560-2010
  2. Recall initiated FDA recalls Z-1953-2010
  3. Recall initiated FDA recalls Z-1952-2010
  4. Cleared FDA 510(k) K130033
  5. Recall initiated FDA recalls Z-1363-2015
  6. Listed FDA GUDID 00880304470361
  7. Recall initiated FDA recalls Z-1828-2016
  8. Recall initiated FDA recalls Z-0818-2018
  9. Recall initiated FDA recalls Z-0212-2026
  10. Registered EUDAMED B-00880304470361

3 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
ToggleLoc with Ziploop
Generic name
Ligament reconstruction instrument set, reusable
Device name
TLoc Elbow Implant System Kit
Model / Ref / Catalog
909854
Primary DI / UDI-DI
00880304470361
Basic UDI-DI
B-00880304470361
510(k) Number
FDA product code
MBI, JDR
EMDN code
P0999 Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Ligament reconstruction instrument set, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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: Ligament reconstruction instrument set, reusable

Cleared under the same submission (K083070)

and 8 more cleared under K083070

Cleared under the same submission (K130033)

and 8 more cleared under K130033

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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