Food, drugs, devices › Ossur H / F
Device recall: Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 62
FDA enforcement event 92207 is a device recall by Ossur H / F of Reykjavik, N/A, initiated 12 May 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Ossur H / F has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ossur H / F, Reykjavik, N/A, Iceland.
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."
Distribution
"US: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN, NC, IN, MS, AL, NY, ID, DE, OK, MA, WI, OR, KY, MD, CO, WV, LA, IL, NJ, CT, MO, NE, WY, AR, SD, PR"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1906-2023 | 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 | 4,190 | Class II | Ongoing | 21 Jun 2023 |
Context
Other enforcement events for Ossur H / F
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Aug 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 | Device | Class II | 1 |
| 25 Mar 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component | Device | Class II | 4 |
| 26 Dec 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Device | Class II | 1 |
| 14 Mar 2016 | Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or ch | Device | Class II | 6 |
| 24 Feb 2016 | Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide pr | Device | Class II | 14 |
| 4 Mar 2015 | LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustabl | Device | Class II | 1 |
| 26 Feb 2015 | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Ar | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN, NC, IN, MS, AL, NY, ID, DE, OK, MA, WI, OR, KY, MD, CO, WV, LA, IL, NJ, CT, MO, NE, WY, AR, SD, PR"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.