The Recall Desk
HighFDA (Devices)·Z-1260-2017·Announced 2017-03-08

Windstone Medical Recalls Anterior Cervical Fusion Packs Due to Sterility Risk

Windstone Medical Packaging is recalling 51 Anterior Cervical Fusion Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

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: The recall involves a medical device where a defect (glove splits/holes) compromises sterility, creating a risk of infection. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 51 kits of the Anterior Cervical Fusion Pack, part numbers AMS2502(A and AMS2502(C). The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. These gloves may contain splits or holes that compromise sterility.

The affected lots have the following numbers and expiration dates: 84343 (5/20/2018), 88052 (11/11/2018), 89579 (11/15/2018), 89709 (12/10/2018), 94934 (1/4/2019), and 95441 (6/3/2019). The products were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington.

Healthcare providers and facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or replacement. Patients who have already received surgery using these kits should contact their healthcare provider if they have concerns regarding infection or other complications.

The recalled product

Product
Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
51

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 (7)

  • Lot numbers and Expiration dates: 84343
  • 5/20/2018 88052
  • 11/11/2018 89579
  • 11/15/2018 89709
  • 12/10/2018 94934
  • 1/4/2019 95441
  • 6/3/2019

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 124 recalled by Windstone Medical Packaging, Inc. 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 124 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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