Recall Z-1906-2023 ยท ISH Component, External, Limb, Ankle/Foot
Ossur H / F
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
| Date | Jun 13, 2023 (initiated May 12, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component change control |
| Action | On 5/12/23, recall notices were sent to customers informing them of the following: a. For affected lots in use, replace both lock body and attachment pin as soon as possible for users that have the following risk factors: - Trouble with socket fit due to volume changes in the residual limb. - Had lock replacement without having new attachment pin installed at the same time. - Have non-Ossur attachment pin in use. - Complaint about loose fit of the socket or locking issues. b. For other users, replace the affected lots of lock body and attachment pin during the next planned consultation, such |
| Quantity | 4,190 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.