RecallRadar

FDA Device recall Z-2421-2015

2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE P…

On 2015-08-26 the FDA classified a Class II recall of 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE P… by Trilliant Surgical, citing the cutting efficiency of the Countersinks was out of specification.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2421-2015
ClassificationClass II
Statusterminated
Initiated2015-07-20
Published2015-08-26
Last updated2026-09-13 11:53 UTC
CompanyTrilliant Surgical
DistributionUS

Product

2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

Reason

The cutting efficiency of the Countersinks was out of specification.

Identifiers

code_infoLot numbers 1362-01 and 1364-01

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2421-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.