Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF/UDI-DI: L-125000/05690967566142; L-621200/05690967596590; L-621000/05690967118334; L-621100/05690967155322; L-692020/05690967128548. Lots: HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, MX220316.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Ossur H / F
- Reason for Recall:
- A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
Product Codes/Lot Numbers:
REF/UDI-DI: L-125000/05690967566142; L-621200/05690967596590; L-621000/05690967118334; L-621100/05690967155322; L-692020/05690967128548. Lots: HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, MX220316.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1906-2023
Related Recalls
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Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.