Moderate riskFDA DeviceClass II

Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment recalled for loose screws

The external screws that secure the cover on the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment may loosen during use and detach. This affects all units with part number 210490 distributed across the United States and several other countries. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Howmedica Osteonics recalls

What to do

  1. Stop using the MICS3 Angled Sagittal Saw Attachment immediately
  2. Contact Howmedica Osteonics Corp. for instructions on inspection or replacement
  3. Check the external screws on your attachment before any future use

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
1098 units
Illnesses reported
None reported
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Classification
Class II
Recall number
Z-1572-2026

In the FDA's words

Description
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL; Distribution: Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand; Affected quantity: 1098 units
Hazard
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

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