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Terminated

TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

FDA Recall Z-1132-2013 · Posted 2013-04-17

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2013-03-06
Date Terminated2019-08-16
Product Quantity23 units

Reason for Recall

One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

Firm Action

Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111025TRIGEN LOW PROFILE BONE SCREWSmith & Nephew, Inc. · 2011-07-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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