SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Summary
The FDA issued a Class II for SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers by SAFE ORTHOPAEDICS LLC. Reason: The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correc.
Details
Source
Device Recall
External ID
Z-1572-2022
Action Date
2022-08-31
Status
Completed
Category
device
Product Description
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Lot/Code Info: KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
Quantity Affected: 8 devices
Reason for Recall
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
Distribution
Distribution was made to MD. There was no government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-03
Company
Chicago, IL
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 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (SAFE ORTHOPAEDICS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SAFE ORTHOPAEDICS LLC have FDA actions?
This is the only FDA action we have on record for SAFE ORTHOPAEDICS LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1572-2022" 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