TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, I
FDA device recall Z-1535-2009 · posted 2009-06-30 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Action taken
- Distributors and consignees were notified by an Urgent: Device Recall letter dated 5/1/09. Consignees were advised to stop using the device and quarantine it immediately. Distributors were instructed to carry out a physical count of all affected product and record the data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer, Inc.; and return recalled product along with the Inventory Return Certification Form to the firm.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXT
- Quantity affected
- 83
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
- Date initiated
- 2009-05-01
- Date posted
- 2009-06-30
- Date terminated
- 2010-11-03
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSFX ANGLED RODS (K003205) | Immedica, Inc. | 2000-12-15 |
| TRANSFX MULTI PIN CLAMP (K991723) | Immedica, Inc. | 1999-07-22 |
| TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION (K990848) | Immedica, Inc. | 1999-05-17 |
| TRANSFX EXTERNAL FIXATION SYSTEM (K984357) | Immedica, Inc. | 1999-03-04 |