—#198035

Product

MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

FDA product code: KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K181280
Affected lot / code info: GTIN 10888277699113, Lot Number ?

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.

Root cause (FDA determination)

Device Design

Action the firm took

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."

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-12-22
Posted by FDA: 2023-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198035. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.