Home › KOROS U.S.A., INC. › Tower Attachment Set

Tower Attachment Set

KOROS U.S.A., INC. · Model 8800-552 · UDI-DI 10840199537232

GAD Prescription

510(k) clearances

1,646

Adverse events (4 deaths)

Recalls

660

Facilities

Description

Tower Attachment Set for 8800-80 Only, Consists of the Following: 1 x 8800-522 Universal Holding Bar w/Long Tower Clamp for 8800-80, 1 x 8800-503 Swivel Side Arm w/Clamp, 2 x 8800-504 Tower Arm Clamp, 2 x 8800-572 Tower Arm Clamp & 1 x 8800-511 Short Suture Boot 3-1/2" Long

Recalls

Date	Firm	Reason
2026-06-05	Integra LifeSciences Corp. (NeuroSciences)	The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110
2025-04-09	MEDLINE INDUSTRIES, LP - Northfield	Three is the potential for the retractors to puncture through the sterile packaging.
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-05-17	SEASPINE ORTHOPEDICS CORPORATION	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-05-17	SEASPINE ORTHOPEDICS CORPORATION	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2023-12-21	Medagent Inc	Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which
2023-05-25	TELEFLEX LLC	There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
2023-05-25	TELEFLEX LLC	There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
2022-12-08	Medtronic Navigation, Inc.	Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

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.