Recall Z-0609-2017— Trilliant Surgical Ltd.

Name: FDA recall Z-0609-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Class II · Terminated

Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2016-09-02, terminated 2017-05-19. It names one FDA 510(k) clearance: K112737. Product: Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD". Reason: Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721..

Recalling firm: Trilliant Surgical Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-09-02
Terminated: 2017-05-19
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K112737 — TIGER HEADLESS CANNULATED SCREWSTrilliant Surgical, Ltd.·cleared 2011-10-20

K-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

Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"

Reason for recall

Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.

Data sourced from openFDA. This site is unofficial and independent of the FDA.