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U.S. Department of Health and Human Services

Class 2 Device Recall Ocular Motility Peg system

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  Class 2 Device Recall Ocular Motility Peg system see related information
Date Initiated by Firm December 20, 2006
Date Posted February 07, 2007
Recall Status1 Terminated 3 on July 12, 2007
Recall Number Z-0396-2007
Recall Event ID 37139
510(K)Number K974203  
Product Classification ocular implant - Product Code MQU
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 CA 92130-2054
For Additional Information Contact Natalie J. Kennel
858-259-4355
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQU and Original Applicant = INTEGRATED ORBITAL IMPLANTS, INC.
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