RegWardenFDA facility compliance records
Recall

Class II — Zimmer, Inc.

Recalling firmZIMMER, INC.
Registered facilityView this company's 10 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonFive complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
ProductOff-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Quantity11 units
DistributionUS Nationwide distribution.
Initiated2026-05-20
Classified2026-06-23
Recall numberZ-2530-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Zimmer, Inc. (Z-2530-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99045/

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