Recall Z-1132-2013— Smith & Nephew Inc
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-03-06, terminated 2019-08-16. It names one FDA 510(k) clearance: K111025. Product: 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. Reason: 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)..
- Recalling firm
- Smith & Nephew Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-06
- Terminated
- 2019-08-16
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.