MEDLINE UNITE recallZ-1047-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 22, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.
FDA root cause category: Device Design
What the company is doing
Medline issued a MEDICAL DEVICE RECALL notice to its direct consignees on 01/05/2023 by US mail and its distributors on 01/07/2023 by email. The notice explained the problem and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected items. Quarantine all affected product. All consignment inventory will be addressed by your local Medline UNITE Sales Representative. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, LP. FURTHER ACTION: Medline is immediately recommending the use of our 1.6mm pre-drill for 2.0mm screws, and our 1.9mm pre-drill for the use of our 2.4mm screws and 2.7mm screws. If you have any questions, please contact 866-359-1704."
Recall details
- Recall number
- Z-1047-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 22, 2022
- Posted by the FDA
- Feb 1, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 190 units
- Product code
- KRR
- FDA submissions
- K181280
- Distribution
- US Nationwide distribution.
Product description
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Code information (models, lots, serial numbers)
GTIN 10888277699113, Lot Number ?
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE UNITE MPN10013Medline Industries, Inc. · REAMER1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91491).
- Z-1045-2023 · Open, ClassifiedMEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
- Z-1046-2023 · Open, ClassifiedMEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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