Class 2 Device Recall Icelock Ratchet

• Date Initiated by Firm: May 12, 2023
• Date Posted: June 13, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1906-2023
• Recall Event ID: 92207
• Product Classification: Component, external, limb, ankle/foot - Product Code ISH
• Product: 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
• Code Information: 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.
• FEI Number: 3003764610
• Recalling Firm/ Manufacturer: Ossur H / F; Grjothals 5; Reykjavik Iceland
• For Additional Information Contact: 3545151300
• Manufacturer 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.
• FDA Determined 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 as liner replacement. If a user suggests there is an issue with the locking mechanism, the lock and attachment pin should be inspected for wear, regardless of lot number. Replace the lock and attachment pin if there are signs of wear; instructions for inspection of wear are attached. c. INFORM applicable personnel handling the products about the added warnings in the Instructions for Use. Firm recommends that you reach out to your patients as soon as possible to inform them about the potential risk of the pin disengaging from the lock, leading to loss of suspension. d. Return unused affected devices. e. Pass this notice to all who need to be aware within your organization or to any other organizations/customers who received affected product. f. Maintain the notice for awareness. g. Complete and return the acknowledgement form to recalls@ossur.com If you have questions or concerns about this notification, please contact customer service. Tel: 1-800-233-6263.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.