Z-1191-2023Class II

stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended...

Name: Z-1191-2023 stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended...
Creator: Stryker GmbH
Published: 2023-02-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-02-07 / Open, Classified

FDA source

Stryker GmbH began a recall of stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct... on 2023-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1191-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-07
Posted: 2023-03-01
Recalling firm: Stryker Corp.
Product: 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
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
FDA root cause: Process change control
Action: The firm issue an URGENT MEDICAL DEVICE RECALLL its consignees by letter on 02/07/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to [email protected] to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Spread awareness of this communication internally until all required actions have been completed within your facility. 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so that Stryker can inform the recipients appropriately.
Quantity in commerce: 488 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1191-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1191-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01

Product code KTT

K153377Class IIHoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH / cleared 2016-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)