Medline recalls specific foot and ankle screws due to observed failure during surgery when used with certain drill bits. This could lead to complications during surgical procedures.
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 a specific type of foot and ankle screw used in surgery because it has failed during procedures when pre-drilled with certain drill bits. This could cause complications for patients undergoing surgery.
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), leading to potential complications. This failure occurs due to excessive torque applied during drilling.
Surgical teams using the recalled screws for foot and ankle procedures are affected. Patients undergoing surgery with these screws are at risk of complications.
Check for the product name 'MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm)' with reference number MMSL2008. The lot number 810304 is also associated with this recall.
Identify the product by checking the reference number MMSL2008 and lot number 810304 on the packaging.
The recall is due to observed intra-operative screw failure when pre-drilled with specific drill bits, which can cause complications during surgery.
Avoid using a 1.3mm drill bit for 2.0mm screws and a 1.6mm drill bit for 2.4mm screws, as this can cause failure.
Look for the reference number MMSL2008 and lot number 810304 on the packaging.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1046-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-1046-2023 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.
