FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
- Recall number
- Z-1960-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
- Status
- Terminated
- Initiated
- 2019-06-10
- Posted
- not on file
- Terminated
- 2020-09-10
- Reason
- Lack of an adequate sterilization validation.
- Root cause
- Under Investigation by firm
- Action
- Medical Device Recall notification letters dated 6/10/19 were sent to customers.
- Quantity
- 92
- Distribution
- 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.
- Lot, serial or model codes
- Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28