Z-2160-2017Class II

Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC...

Name: Z-2160-2017 Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2017-04-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2017-04-26 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of... on 2017-04-26. FDA classified it as Class II and gives the reason as "Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2160-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-26
Posted: 2017-05-25
Terminated: 2020-02-07
Recalling firm: Howmedica Osteonics Corp
Product: Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent via FedEx an "Urgent Medical Device Recall Notification and Business Reply Form" dated April 26, 2017 to their affected customers. For questions call (201) 831-6693.
Quantity in commerce: 437 units
Distribution: US Nationwide distribution in the states of CA, FL, MD and VT
Product codes and lots: Lot Numbers: J49236, V07241, V30655, V47575 and V49404

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2160-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2160-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)