Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate S
FDA device recall Z-0357-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.
- Action taken
- Zimmer Spine sent a Medical Device Correction letter dated October 9, 2013 via FedEx A Medical Device Correction letter, dated October 09, 2013 via FedEx to distributors, Hospitals and Surgeons who have received and/or used the device. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of its contents. Only sterilize the Ratchet Handles external to the instrument tray. Customers were to be notified when replacement trays were available. Customer with questions were instructed to call the Zimmer Customer Call Center at 866-774-6368. UPDATE: July 17, 2014 Zimmer issued another letter to consignees to inform them of a redesigned tray is available and will replace the current tray. A Zimmer representative will conduct the swap-out of the current Rev A tray for the new Rev B design tray. A Return Confirmation Form is asked to be emailed back to CorporateQuality.Postmarket@zimmer.com. For assistance or questions, contact Zimmer Spine Customer Service at 866-774-6368.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 94 Tray sets
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Nationwide and OUS countries include: Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and
- Date initiated
- 2013-10-09
- Date posted
- 2013-11-18
- Date terminated
- 2015-02-24
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRINICA ANTERIOR LUMBAR PLATE SYSTEM (K061353) | Zimmer Spine, Inc. | 2006-08-30 |