FDA Device

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

Hazard

Lack of an adequate sterilization validation.

What You Should Do

Remedy

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

Affected by this recall?

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Products

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Brand
Zimmer Biomet, Inc.
UPC
Lots: 262549 266083  1441011 M642860  2881015 3021022 3081051 266083  2591050  2771027  3231028  MJ54320  MJ54330  MJ54350  MJ54340

Units Affected

92

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