Exactech recalls Equinoxe Reverse Drill Bit Kit (Catalog 321-20-00) for shoulder surgery due to incorrect drill bit configuration. Affected units have serial numbers 5214432 and 5214445.
The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
Exactech recalls a specific shoulder surgery drill bit kit because it contains two 2mm drill bits instead of one 2mm and one 3.2mm bit. This mismatch could cause surgical errors if used incorrectly.
The kit is intended to have one 2mm drill bit and one 3.2mm drill bit for precise bone drilling during shoulder surgery. Having two 2mm bits instead could lead to incorrect drilling depth or bone damage.
Surgical teams using the Equinoxe Reverse Drill Bit Kit for shoulder procedures are affected. Patients undergoing shoulder surgery with this kit are at risk of potential surgical errors.
Check for the catalog number 321-20-00 on the kit. Affected units have serial numbers 5214432 and 5214445. The product is used for shoulder surgery procedures.
Look for serial numbers 5214432 or 5214445 on the kit packaging.
The kit contains two 2mm drill bits instead of one 2mm and one 3.2mm bit as intended for shoulder surgery.
The recall record does not specify a remedy, so no action is required beyond checking if your kit has the affected serial numbers.
The recall indicates a potential for surgical errors but does not specify a risk of serious injury, so it's considered low risk.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0012-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0012-2019 from Exactech. 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.
