stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon
Summary
The FDA issued a Class II for stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic exter by Stryker GmbH. Reason: Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the dis.
Details
Source
Device Recall
External ID
Z-1191-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Lot/Code Info: Serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713, G16331, G16332, G16333, G26278, G29759, G29760, G32730, G32731, G32735, G45119, H30398, H30399, H66392
Quantity Affected: 488 units
Reason for Recall
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-07
Company
Selzach, 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 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 clearances.
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 (Stryker GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker GmbH have FDA actions?
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1191-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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