Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS

FDA device recall Z-0595-2009 · posted 2009-01-02 · Terminated

Recall details

Recalling firm

Ossur

Reason for recall

Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.

Action taken

Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available. If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?

Root cause

Packaging process control

Status

Terminated

Product code

LYT

Quantity affected

3 pouches (4 pins/pouch) = 12 pins

Distribution

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Date initiated

2008-09-26

Date posted

2009-01-02

Date terminated

2010-04-27

Location

Reykjavik, Ireland

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