Summary
The FDA issued a Class II for ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R by Aesculap Implant Systems LLC. Reason: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spina.
Details
Source
Device Recall
External ID
Z-1429-2022
Action Date
2022-07-27
Status
Terminated
Category
device
Product Description
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Lot/Code Info: UDI-DI: 04046964719622
Quantity Affected: 17
Reason for Recall
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
Distribution
United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-11-18
Company
Center Valley, PA
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 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
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 (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1429-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29