Integrated Orbital Implants Inc Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypod Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.

Recommended Action

Per FDA guidance

All domestic customers were notified by phone call on 12//20/2006 which was followed up with a fax and the letter sent registered mail. Internationally, customers were notified by fax, email and mail. Customers were instructed to check their inventory of the product by lot number and visual inspection. They were instructed to isolate the affected inventory. They were provided with alternate instructions on how to use the product as it is, if needed. They were provided with a reply card to complete and fax back to the company. They were instructed that when replacement product becomes available, they will be contacted to arrange for the exchange of the affected product.