Home › NEWDEAL › SURFIX®

SURFIX®

NEWDEAL · Model 219545ND · UDI-DI 10381780045472

HTW Prescription

510(k) clearances

17,868

Adverse events (5 deaths)

114

Recalls

557

Facilities

Description

The drill of diameter 3.0 mm and of total length 190 mm with AO attachment is used to pre-drill before the insertion of the 4.5 mm screws. Using a drilling guide, the screw length can be read from the calibrated scale on the drill. It is also used to drill the bone to prepare the implantation of Large UNI-CLIP® Staples.

Recalls

Date	Firm	Reason
2026-02-11	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de
2026-02-11	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de
2024-01-29	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of
2024-01-29	Waldemar Link GmbH & Co. KG (Mfg Site)	The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01	Flower Orthopedics Corporation	Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-07-30	Paragon 28, Inc.	A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
2021-02-24	Arthrex, Inc.	The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.