Zimmer Biomet recalls specific lots of Comprehensive Mini Stem for potential surgery extension risk if replacement is available. Learn what to do.
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Zimmer Biomet is recalling two lots of the Comprehensive Mini Stem (Item No. 113631) due to a potential risk of surgery extension if a replacement is readily available. This recall affects orthopedic surgery patients who received these specific implants.
The recall is for a potential extension of surgery time if a replacement implant is available. This occurs because the Mini Humeral Stem may be mislabeled as the Bowed IM Stem lot, which could delay the procedure.
Orthopedic surgery patients who received the recalled Comprehensive Mini Stem (Item No. 113631) from Zimmer Biomet. Patients with the specific lot numbers are most at risk.
Check for the product name 'Comprehensive Mini Stem' with Item No. 113631. The recall covers specific lot numbers that were sold during the time period mentioned in the recall notice.
Review the item number on the implant to confirm if it matches the recalled item (Item No. 113631).
The recall is due to a potential risk of surgery extension if a replacement implant is readily available, as the Mini Humeral Stem may be mislabeled as the Bowed IM Stem lot.
Check the item number on the implant to see if it matches the recalled item (Item No. 113631). If it does, contact Zimmer Biomet for further instructions.
The recall states a potential extension of surgery time if a replacement is available, but does not mention serious injury risks.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0591-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0591-2019 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.
