Zimmer Biomet: Comprehensive Reverse Shoulder Instrument Case Recall Due to Sterilization
Zimmer Biomet recalls specific models of Comprehensive Reverse Shoulder Instrument Case (Outer Case Vault Only) due to inadequate sterilization validation. Affected units may not be properly sterilized, posing infection risks during surgical procedures.
Recall notice
Lack of an adequate sterilization validation.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling certain models of the Comprehensive Reverse Shoulder Instrument Case (Outer Case Vault Only) because they lack proper sterilization validation. This could lead to infections during surgical procedures if the instrument case is used without adequate sterilization. Read more at govinfonow.com/recall/67720-zimmer-biomet-comprehensive-reverse-shoulder-instrument-case-recall-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/67720-zimmer-biomet-comprehensive-reverse-shoulder-instrument-case-recall-due-to · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1961-2019
Cite this page
“Zimmer Biomet: Comprehensive Reverse Shoulder Instrument Case Recall Due to Sterilization.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67720-zimmer-biomet-comprehensive-reverse-shoulder-instrument-case-recall-due-to. Based on FDA recall #Z-1961-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1961-2019%22&limit=1).
Why it’s dangerous
The instrument cases lack adequate sterilization validation, meaning they may not be properly sterilized before use. This could lead to infections in patients during surgical procedures if the cases are used without proper sterilization.
Who’s affected
Surgical professionals and hospitals that own or use the recalled instrument cases. Those most at risk are medical staff handling the cases during surgeries.
How to tell if you have this one
Check for the item number 595510 on the case. Affected units include specific lots listed in the recall notice: 251059, 254986, 203752, 260646, 263012, 264753, 2111048, 2111052, 2111050, 2111051, 21110107, 21110106, 21110117, 2291017, 2881019, 3231032, 2981046, 3341019, 831129, 1961120, 21110105, 21110108, 1961120, 3461146, 1081211, 1951228, 3181203, 1411303, 1721312, 2631353, MB33730, ME50120, ME50130, MH50820, 2331407, ML35700, ML56520, 961509, MO93600, MO93610, 1631512, 2261523, 2681520, 443894, 476977, 501920, 530934, 538816.
- Brand
Zimmer Biomet- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1960-2019 | Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509; Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340 | 92 |
| Z-1961-2019 | Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510; 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 | 1257 |
What to do — step by step
Check Case Lot Numbers
Identify the lot numbers on the case to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1961-2019 (June 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1961-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.