Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 sur

FDA device recall Z-2008-2012 · posted 2012-07-13 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.

Action taken

DeRoyal initiated the recall on 6/16/2012 by notifying customers by overnight delivery of letters describing the problem, instructing the customer how to handle inventory on hand, and requesting the customer to destroy the product, fill out the provided notice of destruction form, and return the form to DeRoyal. For questions customers were instructed to call 865-362-1020 or 865-362-1034. For questions regarding this recall call 865-362-2334.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRO

Quantity affected

303 units

Distribution

Nationwide Distribution including SD and NE.

Date initiated

2012-06-16

Date posted

2012-07-13

Date terminated

2012-11-09

Location

Powell, TN