Instrumed International, Inc.: Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names

Recall number

Z-0552-2015

Recalling firm

Instrumed International, Inc.

Product

Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names

Status

Terminated

Initiated

2014-09-08

Posted

2014-12-16

Terminated

2017-11-29

Reason

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Root cause

No Marketing Application

Action

Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.

Quantity

49 lock nuts for titanium traction tongs

Distribution

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Lot, serial or model codes

1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded; CareFusion Item Number: NL9513-T; Lot Number: 012412.   2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: NL9515-T; Lot Number: 012412.   3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical Item Number: 6-1944LN; Lot Number: 012412.   4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments Item Number: 74-0181T; Lot Number: 012412.   5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical Item Number: SS2195T; Lot Number: 012412.   6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: VM85-12925; Lot Number: 012412.

510(k) numbers

not on file

PMA numbers

not on file

Product code

HAX

Firm FEI

1421101

Firm city

Schaumburg

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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