Z-0594-2009

Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S

Name: Z-0594-2009 Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S
Creator: Ossur
Published: 2008-09-26
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2008-09-26 / Terminated / root cause: packaging

FDA source

Ossur began a recall of Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S on 2008-09-26. The reason FDA records is "Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0594-2009
Status: Terminated
Initiated: 2008-09-26
Posted: 2009-01-02
Terminated: 2010-04-27
Recalling firm: Ossur Iceland ehf.
Product: Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S
Product code: LYT Fixation Accessory
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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?
Quantity in commerce: 27 pouches (1 pin/per pouch) = 27 pins
Distribution: Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.
Product codes and lots: Lot Number: 08060410

Product code LYT

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)