Synthes recalls Stem Extractor f/Guide Bar (part 03.401.072) for potential connection screw breakage during shoulder implant procedures. Affected units sold in specific order numbers.
There is a potential for the connection screw of the stem extractor to break.
Synthes is recalling a stem extractor tool used for shoulder implant procedures because its connection screw might break. This could lead to complications during surgery if the tool fails unexpectedly.
The connection screw in the stem extractor could break during use, potentially causing the tool to malfunction. This might lead to complications if the tool fails unexpectedly during shoulder implant procedures.
Orthopedic surgeons and medical professionals who use this stem extractor for Epoca shoulder implants. The risk is low as the breakage is unlikely to cause immediate harm during normal use.
Check for part number 03.401.072 on the stem extractor. Affected units were sold with order numbers 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, or 15-8949.
Look for part number 03.401.072 on the stem extractor. Affected units were sold with specific order numbers.
The recall states there is a potential for the connection screw to break, but it is not described as causing serious injury or death in normal use. The risk is considered low.
Check for part number 03.401.072. Affected units were sold with order numbers 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, or 15-8949.
The recall does not specify a remedy. Check the product details to confirm if it is affected and contact Synthes for further guidance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1514-2018 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1514-2018 from Synthes. 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.
