Recall Z-0770-2023

Acumed LLC · initiated November 29, 2022

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw

Codes / lots: Dual-Trak Clavicle Screws: Batch Number/Part Number/Part Description/UDI Code: 237352 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-237352000000 241396 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-241396000000 251499 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-251499000000 273721 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-273721000000 295968 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-295968000000 305419 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-305419000000 320123 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320123000000 320365 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320365000000 320998 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320998000000 353959 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-353959000000 360734 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-360734000000 361151 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-361151000000 376436 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-376436000000 377113 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw…

Reason for recall

Distribution without Pre-Market Clearance

FDA-determined cause: No Marketing Application

Action taken

On 11/29-30/2022, Acumed LLC sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via USPS First Class with signature required to customers informing them that the Acutrak Headless Compression Screws and the Acutrak 2 Headless Compression Screw Systems were commercialized with a Pre-Market Clearance (510(k)). Customer are instructed to: Product within the scope of this correction does not need to be returned to Acumed. No actions are required as this is a compliance issue and not a patient safety issue. This notification is solely for your awareness. However, 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 RecallNotification@acumed.net. For questions - contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (888) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada)

Details

Recall number
Z-0770-2023
Initiated
November 29, 2022
Posted by FDA
December 23, 2022
Product code
HWC – Screw, Fixation, Bone
Quantity
7,498 units
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, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR…
Recalling firm
Acumed LLC, Hillsboro, OR

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0767-2023 Class IIPart Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S…Distribution without Pre-Market Clearance 11/29/2022Open, Classified
Z-0768-2023 Class IIAcutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S…Distribution without Pre-Market Clearance 11/29/2022Open, Classified
Z-0769-2023 Class IIAcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm…Distribution without Pre-Market Clearance 11/29/2022Open, Classified