Z-0396-2007

Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The...

Name: Z-0396-2007 Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The...
Creator: Integrated Orbital Implants Inc
Published: 2006-12-20
License: https://open.fda.gov/license/

Integrated Orbital Implants Inc / initiated 2006-12-20 / Terminated / root cause: manufacturing process

FDA source

Integrated Orbital Implants Inc began a recall of 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... on 2006-12-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0396-2007
Status: Terminated
Initiated: 2006-12-20
Posted: 2007-02-07
Terminated: 2007-07-12
Recalling firm: Integrated Orbital Implants Inc
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.
Product code: MQU Ocular Peg
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot number: M-50021 Product is not serialized. Note: Lot code assigned by the contract manufacturing firm.

Product code MQU

K974203Class IIPerry-Kolberg (Pk) Titanium Motility/support SystemIntegrated Orbital Implants, Inc. / cleared 1998-02-04

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)