FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- Recall number
- Z-1961-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- 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
- 1257
- 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: 251059 254986 203752 260646 263012 264753 2111048 2111052 2111050 2111051 21110107 21110106 21110117 2291017 2881019 3231032 2981046 3341019 831129 1961120 21110105 21110108 1961120 1961120 1961120 3461146 1961120 1961120 1961120 1961120 1961120 3461146 1081211 1081211 1081211 1951228 1951228 1951228 1951228 1951228 3181203 3181203 3181203 3181203 1411303 1411303¿ 1411303 1721312 1721312 1721312 2631353 2631353 3461146 MB33730 171421 1721312 ME50120 ME50130 1641404 MH50820 1641404 1641404 2331407 1721312 1961120 2291016 3461146 2331407 2331407 ML35700 2331407 2631048 ML56520 2331407 2331407 2331407 2331407 961509 961509 961509 961509 MO93600 MO93610 961509 961509 1631512 1631512 2261523 2261523 2261523 2681520 2681520 2681520 443894 2681520 443894 443894 476977 476977 501920 501920 530934 538816
- 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