Reported Jun 21, 2023 · Ongoing

Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock…

Ossur H / F

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ossur H / F · Grjothals 5 · Reykjavik, N/A · N/A

Is this the product you have?

  • Icelock 125 Ratchet
  • REF
    • L-125000
    • Icelock 600XM Ratchet
  • REF
    • L-621200
    • Icelock 621 Ratchet
  • REF
    • L-621000
    • Icelock 621 Ratchet Adaption Kit
  • REFL-621100; Ratchet Lock Body
  • REFL-692020
Lot codes and dates

5 of 5 products

Products covered by this recall
#BarcodesProduct as published
105690967566142L-125000/05690967566142
205690967596590L-621200/05690967596590
305690967118334L-621000/05690967118334
405690967155322L-621100/05690967155322
505690967128548L-692020/05690967128548. Lots: HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, MX220316.
Amount recalled
4,190

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ossur H / F recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.