Zimmer Biomet recalls Persona Partial Knee Spacer Blocks (sizes 8-14mm) for potential tightness during range-of-motion testing and looseness in final trial, which may affect surgery outcomes.
Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
Zimmer Biomet is recalling Persona Partial Knee Spacer Blocks for sizes 8mm to 14mm due to potential tightness during range-of-motion testing and looseness in the final trial. This could lead to improper surgical outcomes if not addressed.
The spacer blocks may feel tight during initial range-of-motion testing and appear looser in the final trial. This inconsistency could lead to improper alignment or fit during surgery, potentially affecting the procedure's success.
Patients undergoing partial knee arthroplasty surgery who use the recalled spacer blocks are affected. Surgeons and medical teams using these blocks during procedures are at risk of potential surgical complications.
Check for the product model numbers 42-5399-035-08/09/10/12/14 (sizes 8mm to 14mm) or lot numbers listed in the recall notice. The blocks are used in partial knee arthroplasty surgery.
Review the model numbers (42-5399-035-08/09/10/12/14) or lot numbers (63552644, 63579568, etc.) to confirm if your spacer blocks are recalled.
The recall is due to complaints that the spacer blocks may feel tight during range-of-motion testing and appear looser in the final trial, which could affect surgical outcomes.
The official recall notice does not specify a remedy or action for the product. Check the product details to confirm if it's recalled and contact Zimmer Biomet for further guidance.
The recall indicates potential issues with fit during surgery, but the official notice does not mention risks of injury or serious harm. The hazard is described as a possible surgical complication risk.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1240-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1240-2018 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.
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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.
