Z-1744-2015Class II

The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver...

Name: Z-1744-2015 The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver...
Creator: Biomet France S.a.r.l.
Published: 2015-05-14
License: https://open.fda.gov/license/

Biomet France / initiated 2015-05-14 / Terminated / root cause: manufacturing process

FDA source

BIOMET FRANCE S.A.R.L. began a recall of The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac on 2015-05-14. FDA classified it as Class II and gives the reason as "The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1744-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-14
Posted: 2015-06-10
Terminated: 2015-10-27
Recalling firm: Biomet France
Product: The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
Product code: KIH Dispenser, Cement
Reason for recall: The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.
Quantity in commerce: 3
Distribution: Nationwide distribution to MD only
Product codes and lots: Catalog number: 419500 Lot number: 0101296012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1744-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1744-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10

Product code KIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)