MEDLINE recalls specific foot and ankle screws due to observed failure during surgery when used with certain drill bits. Affected models include MMSN2008 (2.0x8mm) sold with lot number 810304. No remedy is stated in the recall notice.
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
MEDLINE is recalling certain foot and ankle screws that have been observed to fail during surgery when used with specific drill bits. This could lead to complications if the screws break while being tightened.
The screws can fail during surgery when pre-drilled with specific drill bits (1.3mm for 2.0mm screws, 1.6mm for 2.4mm screws) due to excessive torque. This failure occurs because the drill bits create too much force when tightening the screws.
Orthopedic surgeons and medical professionals who use these screws during foot and ankle procedures are most at risk. Patients receiving surgery with these screws may also be affected.
Check for the model number MMSN2008 on the screw packaging. The lot number 810304 is associated with this recall. These screws were sold with the GTIN 10193489120387.
Look for the model number MMSN2008 and lot number 810304 on the screw packaging.
The recall is due to observed intra-operative screw failure when pre-drilled with specific drill bits (1.3mm for 2.0mm screws, 1.6mm for 2.4mm screws) causing excessive torque.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the affected model.
The recall indicates observed failure during surgery, but no specific injury details are provided in the notice.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-1045-2023 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-1045-2023 from MEDLINE. 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.
