Agency classClass IIOur severity:High FDA (Devices)·Z-1046-2023·Announced 2023-02-08

Medline UNITE Foot & Ankle Screw Recalled for Intra-Operative Failure

Medline Industries is recalling 420 units of UNITE FOOT & ANKLE Screws nationwide due to observed intra-operative screw failure when used with specific drill bit sizes. The failure occurs due to excessive torque during surgical insertion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The product poses a risk of surgical failure during use, but no explicit reports of patient injury or hospitalization are documented in the source. This meets the rubric criterion for Score 3: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling the UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008. The recalled product consists of 420 units distributed nationwide, with lot number 810304 (GTIN 10193489120707).

The recall is due to observed intra-operative screw failure when used with specific drill bit sizes. When the screws are pre-drilled with a 1.3mm drill bit for 2.0mm screws or a 1.6mm drill bit for 2.4mm screws, excessive torque during insertion can cause the screw to fail during the surgical procedure.

The recalled product

Product: MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Orthopedic
Hazard: screw-failure
intraoperative-failure
Affected units: 420

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

GTIN 10193489120707
Lot Number 810304

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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