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Comprehensive® Instruments 110004265

by Biomet Orthopedics, Inc.

Comprehensive® Instruments 110004265 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K193038 on 28 Oct 2020 (1 earlier submission) and listed in FDA GUDID since 23 Mar 2021 (UDI-DI 00887868462962), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868462962 UDI-DI Date23 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193038 Date28 Oct 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193038 decided 28 Oct 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868462962 listed 23 Mar 2021 Listed

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-1403-2025 FDA Class II initiated 3 Mar 2025

    Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

    • Terminated Z-2216-2017 FDA Class II initiated 26 Apr 2017

    Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.

    • Terminated Z-1859-2017 FDA Class II initiated 17 Feb 2017

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

    • Terminated Z-1658-2008 FDA Unclassified (pre-2012) initiated 13 Mar 2008

    The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien

    • Terminated Z-0660-2013 FDA Class II initiated 6 Dec 12

    Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be prese

Timeline

8 dated events

  1. Recall initiated FDA recalls Z-0660-2013
  2. Cleared FDA 510(k) K060694
  3. Recall initiated FDA recalls Z-1658-2008
  4. Recall initiated FDA recalls Z-1859-2017
  5. Recall initiated FDA recalls Z-2216-2017
  6. Cleared FDA 510(k) K193038
  7. Listed FDA GUDID 00887868462962
  8. Recall initiated FDA recalls Z-1403-2025

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive® Instruments
Generic name
Orthopaedic implant-instrument extension adaptor, reusable
Model / Ref / Catalog
110004265
Primary DI / UDI-DI
00887868462962
510(k) Number
FDA product code
HSD, MBF, KWT, KWS
GMDN term
Orthopaedic implant-instrument extension adaptor, reusable
Device class
Class II
Regulation number
888.3690, 888.3670, 888.3650, 888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant-instrument extension adaptor, reusable

Cleared under the same submission (K060694)

and 8 more cleared under K060694

Cleared under the same submission (K193038)

and 8 more cleared under K193038

Similar devices in this category

Other devices filed under Orthopaedic implant-instrument extension adaptor, reusable.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)