FDA-Device2020-02-26Class II
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Smith & Nephew, Inc.
Hazard
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
Sold states
Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.
Affected count
82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units
Manufactured in
130 & 120 Forbes Blvd, Mansfield, MA, United States
Products
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2020Don't want to check this manually?
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