Z-1906-2023Class II

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

Name: Z-1906-2023 Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000...
Creator: Ossur H / F
Published: 2023-05-12
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2023-05-12 / Open, Classified

FDA source

Ossur H / F began a recall of 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... on 2023-05-12. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1906-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-12
Posted: 2023-06-13
Recalling firm: Ossur Iceland ehf.
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
Product code: ISH Component, External, Limb, Ankle/Foot
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 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 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 [email protected] 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1906-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1906-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-13

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)