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

FDA device recall Z-0275-2014 · posted 2013-11-14 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

HOZ

Quantity affected

726 cases (7242 units)

Distribution

Nationwide Distribution

Date initiated

2013-08-12

Date posted

2013-11-14

Date terminated

2014-08-04

Location

Powell, TN