EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an
Summary
The FDA issued a Class II for EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated by DePuy Spine, Inc.. Reason: Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may no.
Details
Source
Device Recall
External ID
Z-1323-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
Product Description
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
Lot/Code Info: UDI-DI: 04260557770658 Lot Number: E20CL0603
Quantity Affected: 61 units
Reason for Recall
Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
Distribution
Distribution US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-20
Company
Raynham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Spine, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DePuy Spine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Spine, Inc. have FDA actions?
DePuy Spine, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1323-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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