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Compress® Device 178543

by Biomet Orthopedics, Inc. United States GUDID

Product code KRO

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304260689 UDI-DIDate24 Oct 2015ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

6 recalls · FDA

  • 6 recalls, same reason

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

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

Specification

GUDID · synced 23 Oct 2026

Trade Name
Compress® Device
Generic Name
Humeral centering sleeve
Model / Ref / Catalog
178543
Primary DI / UDI-DI
00880304260689
510(k) Number
FDA Product Code
KRO, LZO, KWZ, KWY, LPH, JDI, MEH
GMDN Term
Humeral centering sleeve
Device Class
Class II
Regulation Number
888.3510, 888.3353, 888.3310, 888.3390, 888.3358, 888.3350
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • FDA UDI 1ee9b606-67c2-4552-9e66-2cc9a7950425 36 fields · synced 23 Oct 2026