Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Lef

FDA device recall Z-1218-2024 · posted 2024-02-29 · Open, Classified

Recall details

Recalling firm

Acumed LLC

Reason for recall

Distribution without Pre-Market Clearance

Action taken

Between the dates of January 24-25, 2023 Acumed Urgent: Medical Device Correction Notification to consignees via: USPS. Acumed asked consignees to take the following steps: This notice is solely for your awareness. Products within the scope of this correction do not need to be returned to Acumed. Until the products have received Pre-Market clearance, please post this Customer Notification on or near the affected products to be continuously informed of the situation. Physicians are urged to notify Acumed of any adverse events or product safety issues. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Complete and submit the report Online " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. Please complete the survey on Page 8 of this letter to indicate your receipt of this notice and to acknowledge you have read the content of this notice. Return the survey via email to RecallNotificationGroup@acumed.net.

Root cause

No Marketing Application

Status

Open, Classified

Product code

HRS

Quantity affected

2,952,121 units

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,

Date initiated

2023-12-19

Date posted

2024-02-29

Location

Hillsboro, OR