Recall Z-0911-2026 ยท NWN Laparoscopic Bone Anchor Urethropexy Instrument Kit
Medline Industries, LP
DEXLOCK Achilles Repair Implant Kits, MAKT4520
| Date | Dec 11, 2025 (initiated Nov 11, 2025) |
| Status | Open, Classified |
| Reason | There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure. |
| Root cause | Under Investigation by firm |
| Action | Firm began notifying consignees on 11/11/2025 via Urgent Medical Device Recall letters. Customers have been instructed to over-label kits with a sticker instructing them to not use the drill guide within the Achilles Kit and to use the reusable 3.6mm drill guide from the Soft Tissue Instrument Tray. Customers who do not have a Soft Tissue Instrument Tray have been instructed to notify Medline so that a tray can be provided. Customers were instructed to quarantine all affected product in stock and return a completed response form to Medline. Upon receipt of the response form, the firm will th |
| Quantity | 163 US |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.