FDA Medical Device Recalls (openFDA)
Medline Industries, LP: DEXLOCK Achilles Repair Implant Kits, MAKT4520
- Recall number
- Z-0911-2026
- Recalling firm
- Medline Industries, LP
- Product
- DEXLOCK Achilles Repair Implant Kits, MAKT4520
- Status
- Open, Classified
- Initiated
- 2025-11-11
- Posted
- 2025-12-11
- Terminated
- not on file
- 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 then provide over-labels to place on affected inventory. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- 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.
- Lot, serial or model codes
- Lot 19019 UDI-DI 10193489131703
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NWN
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28