Zimmer Biomet recalls 6.5mm x 125mm x 16mm Cannulated Screws due to incorrect labeling of a smaller screw size. This could lead to improper use in medical procedures.
One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Zimmer Biomet is recalling a specific size of surgical screws because they were incorrectly labeled as a larger size. This could cause improper use in medical procedures if the wrong screw is used.
The screws are labeled as 6.5mm x 125mm x 16mm but are actually 3.5mm x 24mm Cortical Locking screws. Using the wrong size could lead to improper fixation in medical procedures, potentially causing complications.
Patients and medical professionals who have received the incorrectly labeled screws for procedures like slipped capital femoral epiphysis or pediatric fractures. Those using the screws in the specified medical applications are most at risk.
Check for the item number 110009948 with the UDI code (01)00887868111327 (17)270421 (10)120910. The screws are used in specific medical procedures like slipped capital femoral epiphysis or pediatric fractures.
Look for the item number 110009948 and UDI code (01)00887868111327 (17)270421 (10)120910 on the screw packaging.
The screws are labeled as 6.5mm x 125mm x 16mm but are actually 3.5mm x 24mm Cortical Locking screws.
These screws are used in procedures like slipped capital femoral epiphysis, pediatric femoral neck fractures, tibial plateau fractures, SI joint disruptions, intercondylar femur fractures, subtalar arthrodesis, and fixation of pelvis and iliosacral joint.
Check for the item number 110009948 with the UDI code (01)00887868111327 (17)270421 (10)120910 on the screw packaging.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1064-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1064-2018 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.
