Recall Record

Hillsboro, OR, United States

Acumed LLC recalls

5 recalls recorded since 2018, most recently on 28 May 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.

Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
28 May 2026
Reason
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Distribution
US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.
Initiated
Voluntary: Firm initiated
Recall number
Z-2532-2026

Ongoing Class II Medical devices

Recall started
19 December 2023
Reason
Distribution without Pre-Market Clearance
Distribution
Worldwide distribution - US Nationwide and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, ID, IE, IL, IT, JP, KR, KW, MX, MY, NZ, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, US, ZA.
Initiated
Voluntary: Firm initiated
Recall number
Z-1218-2024

Ongoing Class II Medical devices

Recall started
27 November 2023
Reason
Due to potential breakage during use.
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia.
Initiated
Voluntary: Firm initiated
Recall number
Z-0618-2024

Ongoing Class II Medical devices

Recall started
29 November 2022
Reason
Distribution without Pre-Market Clearance
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0768-2023, Z-0770-2023, Z-0769-2023, Z-0767-2023

Completed Class II Medical devices

Recall started
9 March 2022
Reason
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0958-2022, Z-0959-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.