🔍 RecallPedia

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Class I - Dangerous
🏥 Medical Devices Recalled: February 6, 2024 Waldemar Link GmbH & Co. KG (Mfg Site) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code (UDI/DI): 127-940/26 (04026575335572) , 127-940/35 (04026575335589) , 127-941/26 (04026575335596) , 127-941/35 (04026575335602) , 127-942/26 (04026575335619) , 127-942/35 (04026575335626) , 127-943/26 (04026575335633) , 127-943/35 (04026575335640) , 127-944/26 (04026575335657) , 127-944/35 (04026575335664) , 127-945/26 (04026575335671) , 127-945/35 (04026575335688) , 127-946/26 (04026575335695) , 127-946/35 (04026575335701) , 127-947/26 (04026575335718) , 127-947/35 (04026575335725), 127-948/26 (04026575335732) , 127-948/35 (04026575335749) , 127-949/26 (04026575335756) , 127-949/35 (04026575335763) , 127-950/26 (04026575335770) , 127-950/35 (04026575335787) , 127-951/26 (04026575335794) , 127-951/35 (04026575335800) , 127-952/26 (04026575335817) , 127-952/35 (04026575335824) , 127-953/26 (04026575335831) , 127-953/35 (04026575335848) , 127-954/26 (04026575335855) , 127-954/35 (04026575335862) , 127-955/26 (04026575335879) , 127-955/35 (04026575335886), 127-956/26 (04026575335893) , 127-956/35 (04026575335909) , 127-957/26 (04026575335916) , 127-957/35 (04026575335923) , 127-958/26 (04026575335930) , 127-958/35 (04026575335947) , 127-959/26 (04026575335954) , 127-959/35 (04026575335961) , 127-960/26 (04026575335978) , 127-960/35 (04026575335985) , 127-961/26 (04026575335992) , 127-961/35 (04026575336005) , 127-962/26 (04026575336012) , 127-962/35 (04026575336029) , 127-963/26 (04026575336036) , 127-963/35 (04026575336043);
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason for Recall:
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Product Codes/Lot Numbers:

Product Code (UDI/DI): 127-940/26 (04026575335572) , 127-940/35 (04026575335589) , 127-941/26 (04026575335596) , 127-941/35 (04026575335602) , 127-942/26 (04026575335619) , 127-942/35 (04026575335626) , 127-943/26 (04026575335633) , 127-943/35 (04026575335640) , 127-944/26 (04026575335657) , 127-944/35 (04026575335664) , 127-945/26 (04026575335671) , 127-945/35 (04026575335688) , 127-946/26 (04026575335695) , 127-946/35 (04026575335701) , 127-947/26 (04026575335718) , 127-947/35 (04026575335725), 127-948/26 (04026575335732) , 127-948/35 (04026575335749) , 127-949/26 (04026575335756) , 127-949/35 (04026575335763) , 127-950/26 (04026575335770) , 127-950/35 (04026575335787) , 127-951/26 (04026575335794) , 127-951/35 (04026575335800) , 127-952/26 (04026575335817) , 127-952/35 (04026575335824) , 127-953/26 (04026575335831) , 127-953/35 (04026575335848) , 127-954/26 (04026575335855) , 127-954/35 (04026575335862) , 127-955/26 (04026575335879) , 127-955/35 (04026575335886), 127-956/26 (04026575335893) , 127-956/35 (04026575335909) , 127-957/26 (04026575335916) , 127-957/35 (04026575335923) , 127-958/26 (04026575335930) , 127-958/35 (04026575335947) , 127-959/26 (04026575335954) , 127-959/35 (04026575335961) , 127-960/26 (04026575335978) , 127-960/35 (04026575335985) , 127-961/26 (04026575335992) , 127-961/35 (04026575336005) , 127-962/26 (04026575336012) , 127-962/35 (04026575336029) , 127-963/26 (04026575336036) , 127-963/35 (04026575336043);

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1299-2024

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Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

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