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Medical Device Recalls
Class 2 Recall
Ocular Motility Peg system

See Related Information
Date Recall
Initiated		 December 20, 2006
Date Posted February 07, 2007
Recall Number Z-0396-2007
Product 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 hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg.
Code Information Lot number: M-50021 Product is not serialized. Note: Lot code assigned by the contract manufacturing firm.
Recalling Firm/
Manufacturer		 Integrated Orbital Implants Inc
12625 High Bluff Dr Ste 314
San Diego , California 92130-2054
For Addition Information Contact Natalie J. Kennel
858-259-4355
Reason For
Recall		 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.
Action 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.
Quantity in Commerce 234
Distribution Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.
 

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