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Orthopedic Salvage System (OSS) 151849

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

14 closed

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 Number00880304674516 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

14 recalls · FDA

    • Terminated Z-0623-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-2147-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-0590-2019 FDA Class II initiated 10 Oct 2018

    Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

    • Terminated Z-0303-2018 FDA Class II initiated 5 Jun 2017

    Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

    • Terminated Z-0417-2012 FDA Unclassified (pre-2012) initiated 1 Nov 2011

    Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).

  • 6 recalls, same reason

    • Terminated Z-1530-2009 FDA Unclassified (pre-2012) initiated 19 May 2009
    • Terminated Z-1526-2009 FDA Unclassified (pre-2012) initiated 19 May 2009
    • Terminated Z-1527-2009 FDA Unclassified (pre-2012) initiated 19 May 2009
    • Terminated Z-1528-2009 FDA Unclassified (pre-2012) initiated 19 May 2009
    • Terminated Z-1531-2009 FDA Unclassified (pre-2012) initiated 19 May 2009
    • Terminated Z-1529-2009 FDA Unclassified (pre-2012) initiated 19 May 2009

    The retaining ring may fall out of the instrument during surgery.

  • 3 recalls, same reason

    • Terminated Z-1881-2008 FDA Unclassified (pre-2012) initiated 15 May 2008
    • Terminated Z-1879-2008 FDA Unclassified (pre-2012) initiated 15 May 2008
    • Terminated Z-1880-2008 FDA Unclassified (pre-2012) initiated 15 May 2008

    Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Orthopedic Salvage System (OSS)
Generic Name
Knee arthroplasty wedge
Model / Ref / Catalog
151849
Primary DI / UDI-DI
00880304674516
510(k) Number
FDA Product Code
JDI, KRO, LPH, KWZ, KWY, LZO, KWT, MEH
GMDN Term
Knee arthroplasty wedge
Device Class
Class II
Regulation Number
888.3350, 888.3510, 888.3358, 888.3310, 888.3390, 888.3353, 888.3650
GUDID distribution status
In Commercial Distribution

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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