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Mg II® 5110-70-20

by Zimmer, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

70 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 Number00889024186378 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

70 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1143-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1124-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1132-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

  • 2 recalls, same reason

    • Terminated Z-1021-2014 FDA Class II initiated 11 Oct 2013
    • Terminated Z-1037-2014 FDA Class II initiated 11 Oct 2013

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

  • 65 recalls, same reason

    • Terminated Z-1571-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1583-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1598-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1574-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1591-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1597-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1580-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1584-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1555-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1560-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1603-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1589-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1608-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1573-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1569-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1565-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1575-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1593-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1552-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1561-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1604-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1581-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1576-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1550-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1556-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1559-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1587-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1562-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1602-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1601-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1578-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1563-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1592-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1609-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1564-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1605-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1582-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1590-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1599-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1586-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1611-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1547-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1551-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1549-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1594-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1577-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1610-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1567-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1607-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1595-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1600-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1579-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1588-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1548-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1557-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1554-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1596-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1566-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1570-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1553-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1568-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1585-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1558-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1572-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1606-2012 FDA Not yet classified initiated 24 Feb 2012

    Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mg II®
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Reference
5110-70-20
Primary DI / UDI-DI
00889024186378
510(k) Number
FDA Product Code
JWH
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
Not in Commercial Distribution
Size
Length — 20 Millimeter

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • 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