The Recall Desk
HighFDA (Devices)·Z-1045-2023·Announced 2023-02-08

MEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure

MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.

What this means for you

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: FDA Class II recall for a risk-of-harm surgical product where intra-operative failure has been observed but no injuries or illnesses are reported in the source documentation. Under the rubric, observed risk-of-harm products without reported injury score as High (3).

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling UNITE Foot and Ankle Screws (Model MMSN2008, 2.0x8mm, Non-Locking, Mini T8). The recall affects 420 units with Lot Number 810304 distributed nationwide (GTIN 10193489120387).

The recall is due to observed intra-operative screw failure. These surgical screws may fail when pre-drilled with a 1.3mm drill bit and installed with excessive torque during surgery.

Healthcare providers, hospitals, and surgical facilities should verify they do not have affected units in stock and take appropriate action regarding inventory of this product.

The recalled product

Product
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Orthopedic Surgical Hardware
Hazard
  • screw-failure
  • surgical-complication

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 10193489120387
  • Lot Number 810304

Distribution

Distributed nationwide across the United States.

Related recalls

Same category