Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howm
FDA device recall Z-1095-2011 · posted 2011-02-11 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6).
- Action taken
- The firm, Stryker, sent a "UPDATED (Corrected Lot Code) URGENT PRODUCT RECALL" letter dated January 6, 2011, via Fed Ex ,with return receipt to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to fax the attached Product Recall Acknowledgement form to (201) 831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product, and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team at (201) 831-5028.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 15 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-12-22
- Date posted
- 2011-02-11
- Date terminated
- 2012-10-03
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM (K031729) | Howmedica Osteonics Corp. | 2003-09-02 |