Recall Z-2054-2012— Synthes (USA) Products LLC

Name: FDA recall Z-2054-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-31

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2012-05-31, terminated 2015-08-31. It names one FDA 510(k) clearance: K020517. Product: Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.. Reason: USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right)..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-31
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K020517 — SYNTHES DUAL-OPENING USSSynthes (Usa)·cleared 2002-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.

Reason for recall

USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right).

Data sourced from openFDA. This site is unofficial and independent of the FDA.