Z-0275-2014Class II

DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk...

Name: Z-0275-2014 DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk...
Creator: DeRoyal Industries Inc
Published: 2013-08-12
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2013-08-12 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning... on 2013-08-12. FDA classified it as Class II and gives the reason as "One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product". 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-0275-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Posted: 2013-11-14
Terminated: 2014-08-04
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
Product code: HOZ Sponge, Ophthalmic
Reason for recall: One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: DeRoyal Industries sent an Urgent Voluntary Recall letter dated August 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease usage and return the product to: DeRoyal Recalls RA#: Eye Spears 1755 Hwy 33 South New Tazewell, TN 37825 Ship via UPS Ground using Shipper #312780 Distributors were requested to notify their consignees of the same. The recall is extended to the user level. Customers with questions were instructed to call 1-800-251-9864. For questions regarding this recall call 865-362-2334.
Quantity in commerce: 726 cases (7242 units)
Distribution: Nationwide Distribution
Product codes and lots: Lot Number 32794811

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0275-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0275-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

Product code HOZ

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)