Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla
Summary
The FDA issued a Class II for Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral med by Waldemar Link GmbH & Co. KG (Mfg Site). Reason: A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains i.
Details
Source
Device Recall
External ID
Z-2481-2023
Action Date
2023-09-06
Status
Ongoing
Category
device
Product Description
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Lot/Code Info: UDI-DI: 04026575284658 Lot Codes: C010108, C151519
Quantity Affected: 6 units
Reason for Recall
A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
Distribution
IN,GA, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-26
Company
Norderstedt, N/A
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 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 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 (Waldemar Link GmbH & Co. KG (Mfg Site)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waldemar Link GmbH & Co. KG (Mfg Site) have FDA actions?
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2481-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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