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.
Lack of an adequate sterilization validation.
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.
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.
Surgical professionals and hospitals that own or use the recalled instrument cases. Those most at risk are medical staff handling the cases during surgeries.
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.
Identify the lot numbers on the case to determine if it is affected by this recall.
The instrument case lacks adequate sterilization validation, which could lead to infections during surgical procedures if not properly sterilized.
The recall notice does not specify a remedy, so contact Zimmer Biomet directly for guidance.
Affected lots include 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.
The recall notice does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1961-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1961-2019 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
