Medical device recalls Moderate risk

Trilliant Surgical Ltd. recalls Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-…

Recall date
September 2, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0609-2017
FDA classification
Class II
Brand / firm
Trilliant Surgical Ltd.
Sold / distributed
CA, AZ, WI, FL, NJ, OH

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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"

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