Instrumed International, Inc. Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
1) Instrumed Product Name: Hudson Brace, snap lock chuck, Instrumed Product Number: 600-00479, Trade Name: Telelfex Medical, Telelfex Medical Product Name: Hudson Brace, snap lock chuck, Telelfex Medical Item Number: P-22880, Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck, Instrumed Product Number: 600-00479, Trade Name: Boss Instruments, Boss Instruments Product Name: Hudson Brace, snap lock chuck, Boss Instruments Item Number: 74-0121, Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only, Instrumed Product Number: 600-00484, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Hudson Brace Only, Symmetry Surgical Item Number: 57-6004, Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only, Instrumed Product Number: 600-00484, Trade Name: Teleflex Medical, Teleflex Medical Product Name: Hudson Brace Only, Teleflex Medical Item Number: P-22881, Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only, Instrumed Product Number: 600-00484, Trade Name: CareFusion, CareFusion Product Name: Hudson Brace Only, CareFusion Item Number: VM85-1233, Lot Number: 100211. 6) Instrumed Product Name: Hudson Brace Only, Instrumed Product Number: 600-00484, Trade Name: Boss Instruments, v Product Name: Hudson Brace Only with Tumb Screw Lock, Boss Instruments Item Number: 74-0122, Lot Number: 100211.
Products Sold
1) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments Item Number: 74-0121; Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical Item Number: 57-6004; Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical Item Number: P-22881; Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion Item Number: VM85-1233; Lot Number: 100211. 6) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments Item Number: 74-0122; Lot Number: 100211.
Instrumed International, Inc. is recalling Hudson braces are bone cutting and drilling instruments that are used without a power source on a pa due to The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026