AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist Acutrak Compression Screw AI-0
FDA device recall Z-0769-2023 · posted 2022-12-23 · Open, Classified
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Distribution without Pre-Market Clearance
- 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)
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- HWC
- Quantity affected
- 80,805 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,
- Date initiated
- 2022-11-29
- Date posted
- 2022-12-23
- Location
- Hillsboro, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (K221333) | Acumed, LLC | 2022-12-29 |