Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-2160-2017

Z-2160-2017 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

FDA device recall Z-2160-2017 was initiated by Stryker Howmedica Osteonics Corp. on April 26, 2017 and is designated Class II. 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… The recall status is terminated (terminated February 7, 2020). Affected quantity: 437 units.

Recall Details

Product Type
Devices
Report Date
May 31, 2017
Initiation Date
April 26, 2017
Termination Date
February 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
437 units

Product Description

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.

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.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, MD and VT

Code Information

Lot Numbers: J49236, V07241, V30655, V47575 and V49404

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  • Z-2791-2016 Class II — Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended (June 30, 2016)
  • Z-2792-2016 Class II — Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the (June 30, 2016)
  • Z-2377-2016 Class II — Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541 (June 23, 2016)
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FDA data resources