Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279
FDA device recall Z-1052-2015 · posted 2015-02-04 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
- Action taken
- Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OIY
- Quantity affected
- 67963
- Distribution
- Worldwide Distribution - USA Nationwide including DC, and PR and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Dominican Republic, France, Germany, India, Iran, Israel, Italy,
- Date initiated
- 2014-12-11
- Date posted
- 2015-02-04
- Date terminated
- 2015-10-23
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM (K123459) | Zimmer, Inc. | 2013-02-22 |