Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve a
FDA device recall Z-0396-2007 · posted 2007-02-07 · Terminated
Recall details
- Recalling firm
- Integrated Orbital Implants Inc
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQU
- Quantity affected
- 234
- Distribution
- Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.
- Date initiated
- 2006-12-20
- Date posted
- 2007-02-07
- Date terminated
- 2007-07-12
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (K974203) | Integrated Orbital Implants, Inc. | 1998-02-04 |