Device recall: A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion…
Class II FDA enforcement event 69471. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Class II, in the words of FDA
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
Instrumed International, Inc. started this device recall on 8 Sep 2014. The firm address in the FDA record is in Schaumburg, IL. FDA put the recall in Class II. FDA event 69471 has 28 product records. The first FDA enforcement report date is 17 Dec 2014. The record gives the status Terminated, with the termination date 29 Nov 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Recalling firm
Instrumed International, Inc., Schaumburg, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
28 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0532-2015 | A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus. | 26 tenaculum hooks | Class II | Terminated | 17 Dec 2014 |
| Z-0533-2015 | An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or… | 26 endometrial suction curettes | Class II | Terminated | 17 Dec 2014 |
| Z-0534-2015 | A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names. | 81 clamps | Class II | Terminated | 17 Dec 2014 |
| Z-0535-2015 | A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names. | 11 trocars | Class II | Terminated | 17 Dec 2014 |
| Z-0536-2015 | An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I… | 479 valvulotomes | Class II | Terminated | 17 Dec 2014 |
| Z-0537-2015 | Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name. | 13 drills | Class II | Terminated | 17 Dec 2014 |
| Z-0538-2015 | A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL,… | 421 clamps | Class II | Terminated | 17 Dec 2014 |
| Z-0539-2015 | Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names. | 74 trephines | Class II | Terminated | 17 Dec 2014 |
| Z-0540-2015 | 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. | 8 Hudson braces | Class II | Terminated | 17 Dec 2014 |
| Z-0541-2015 | Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name. | 1 Hudson cerebellar extension | Class II | Terminated | 17 Dec 2014 |
| Z-0542-2015 | Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names. | 9 perforating drills | Class II | Terminated | 17 Dec 2014 |
| Z-0543-2015 | Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names. | 4 Cushing burrs | Class II | Terminated | 17 Dec 2014 |
| Z-0544-2015 | Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names. | 16 Hudson burrs | Class II | Terminated | 17 Dec 2014 |
| Z-0545-2015 | McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names. | 4 McKenzie perforator drills | Class II | Terminated | 17 Dec 2014 |
| Z-0546-2015 | D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names. | 2 D'errico perforator drills | Class II | Terminated | 17 Dec 2014 |
| Z-0547-2015 | McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. | 3 McKenzie enlarging burrs | Class II | Terminated | 17 Dec 2014 |
| Z-0548-2015 | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names. | 5 Hudson cranial drill sets | Class II | Terminated | 17 Dec 2014 |
| Z-0549-2015 | Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name. | 3 Galt trephines | Class II | Terminated | 17 Dec 2014 |
| Z-0550-2015 | Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names. | 190 Gardner-Wells traction tongs | Class II | Terminated | 17 Dec 2014 |
| Z-0551-2015 | Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names. | 67 replacement screw non-springloaded traction tongs | Class II | Terminated | 17 Dec 2014 |
| Z-0552-2015 | 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 | 49 lock nuts for titanium traction tongs | Class II | Terminated | 17 Dec 2014 |
| Z-0553-2015 | Titanium fixation screws, springloaded 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 Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names. | 22 titanium fixation screws, springloaded | Class II | Terminated | 17 Dec 2014 |
| Z-0554-2015 | Traction tong replacement screws, non-springloaded 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, Boss Instruments, and Stealth Surgical brand names. | 17 traction tong replacement screws, non-springloaded | Class II | Terminated | 17 Dec 2014 |
| Z-0555-2015 | Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name. | 2 Gardner-Wells wrenches | Class II | Terminated | 17 Dec 2014 |
| Z-0556-2015 | CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names. | 790 distractor screws | Class II | Terminated | 17 Dec 2014 |
| Z-0557-2015 | Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. | 5 Cloward Spanner gauges | Class II | Terminated | 17 Dec 2014 |
| Z-0558-2015 | Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium… | 23 tonometers | Class II | Terminated | 17 Dec 2014 |
| Z-0559-2015 | Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea)… | 3 Schoitz weights | Class II | Terminated | 17 Dec 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 28Median of the firm: 28
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 May 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to | Device | Class II | 10 |
Official channels
- FDA enforcement report Z-0532-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 69471. https://recallregister.com/fda/ii/69471/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- What quantity of product is in FDA event 69471?
- The event has 28 product records. The first record gives this quantity:
26 tenaculum hooks
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.