Z-0837-2019Class II

OMNI K1 Broach Handle, Product Code HS-10054

Name: Z-0837-2019 OMNI K1 Broach Handle, Product Code HS-10054
Creator: OMNIlife science Inc.
Published: 2018-11-29
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2018-11-29 / Terminated

FDA source

OMNIlife science Inc. began a recall of OMNI K1 Broach Handle, Product Code HS-10054 on 2018-11-29. FDA classified it as Class II and gives the reason as "There is a potential for the inner pin of the handle to become loose and fall out". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0837-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-29
Posted: 2019-02-14
Terminated: 2020-04-16
Recalling firm: Omni Life Science, Inc.
Product: OMNI K1 Broach Handle, Product Code HS-10054
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: There is a potential for the inner pin of the handle to become loose and fall out.
FDA root cause: Under Investigation by firm
Action: Customers were contacted via telephone on 11/29/18. Advisory Notice letters were also distributed to customers on 12/14/18.
Quantity in commerce: 7
Distribution: The products were distributed to the following US states: CA, GA, SC, and UT.
Product codes and lots: Lot Number MM0118

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0837-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0837-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14

Product code LXH

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)