Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS
FDA Recall Z-0596-2009 · Posted 2009-01-02
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Recalling FirmOssur
Recall StatusTerminated
Product CodeLYT
Date Initiated2008-09-26
Date Terminated2010-04-27
Product Quantity1 pouches (4 pins/pouch) = 4 pin
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.
Firm Action
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
Distribution Pattern
Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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