FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. d.b.a. Integra Pain Management: INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
- Recall number
- Z-2684-2016
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Product
- INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
- Status
- Terminated
- Initiated
- 2016-08-04
- Posted
- not on file
- Terminated
- 2016-12-19
- Reason
- Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.
- Root cause
- Other
- Action
- Integra sent an Urgent Medical Device letter dated August 4, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return unused, affected product. Confirmation of the recall notification delivery via delivery verifiable email; Return of Recall Acknowledgement form; Return & disposition of unused, affected product, if the customer in their response indicates they have affected devices. Any products returned to Integra as a result of the recall will be stored in a segregated, labeled area. Recalled products that are returned will be dispositioned as scrap and destroyed. Any Lidocaine returned with the products will be dispositioned as directed in the Hospira Inc. Drug Recall Notification. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210. For further questions, please call (801) 886-9505.
- Quantity
- 200 packages (20 cases)
- Distribution
- US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee.
- Lot, serial or model codes
- The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556;
- 510(k) numbers
- ["K943319"]
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28