Encore Medical recalls AltiVate Humeral Socket Shell Trial (REF 803-06-152) due to broken screws and retaining clips that may cause injury during surgery.
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Encore Medical is recalling a specific orthopedic surgical instrument used for trial implants. Broken or missing screws and retaining clips could lead to injury during surgery if the instrument fails.
The instrument may have broken or missing screws and retaining clips due to screw tolerance and material strength issues. This could cause the instrument to fail during surgery, potentially leading to injury to the patient.
Orthopedic surgeons and medical facilities using the AltiVate Humeral Socket Shell Trial (REF 804-06-152) for surgical trials. Surgeons using this instrument without checking for screw integrity are at risk.
Check for the model number REF 804-06-152 on the instrument. The product was sold with lot codes 183312L03, 200006L01, and 224643L01.
Inspect the instrument for broken or missing screws and retaining clips before use.
The product may have broken or missing screws and retaining clips, which could cause injury during surgery. Do not use until checked.
Check for broken or missing screws and retaining clips. If found, stop using the instrument and contact Encore Medical for further instructions.
Look for the model number REF 804-06-152 and lot codes 183312L03, 200006L01, or 224643L01.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1241-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-1241-2018 from Encore Medical. 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.
