Stryker sagittal saw attachment cover screws may loosen and detach
Howmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because the external screws securing the cover to the saw housing may loosen and detach during use.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: screws may detach from a surgical saw during use, and no injuries are stated in the source.
Plain-English summary
Howmedica Osteonics Corp. is recalling the MICS3 Angled Sagittal Saw Attachment, part number 210490. About 1,098 units were distributed nationwide in the United States and to Australia, Germany, Belgium, France, Spain, the United Kingdom and New Zealand. The FDA has classified this recall as Class II.
A potential issue was identified with the torque strength on the external screws of the attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
All lot numbers are affected. The device carries UDI 07613327523874.
Facilities can identify affected attachments by the part number and UDI above, and may contact Howmedica Osteonics Corp. for further information.
The recalled product
- Product
- MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 1,098
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 (3)
- Part Number: 210490
- UDI: (01)07613327523874(10)TU6563205RP
- Lot numbers: ALL
Distribution
Distributed nationwide across the United States.
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