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Percutaneous Soft Anchor Short 1.4mm Guide SSI008661

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024712034 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-3252-2018 FDA Class II initiated 3 Aug 2018

    Expiration date incorrectly listed on the label

    • 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-3109-2011 FDA Unclassified (pre-2012) initiated 21 Jul 2011

    The device packaging was punctured by the device, resulting in loss of implant sterility.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Percutaneous Soft Anchor Short 1.4mm Guide
Generic Name
Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog
SSI008661
Primary DI / UDI-DI
00889024712034
510(k) Number
FDA Product Code
MBI
GMDN Term
Orthopaedic implantation sleeve, reusable
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K110145)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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