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Terminated

Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

FDA Recall Z-1961-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeFSM
Date Initiated2019-06-10
Date Terminated2020-09-10
Product Quantity1257

Reason for Recall

Lack of an adequate sterilization validation.

Firm Action

Medical Device Recall notification letters dated 6/10/19 were sent to customers.

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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