MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008

FDA device recall Z-1046-2023 · posted 2023-02-01 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

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.

Action taken

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."

Root cause

Device Design

Status

Open, Classified

Product code

KRR

Quantity affected

420 units

Distribution

US Nationwide distribution.

Date initiated

2022-12-22

Date posted

2023-02-01

Location

Northfield, IL

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