Synthes (USA) Products LLC: Medical Device Recall in 2012 - (Recall #: Z-2054-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 31, 2012

Date Posted: August 1, 2012

Recall Number: Z-2054-2012

Event ID: 62324

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).

Status: Terminated

Product Quantity: 12 units

Code Information:

Catalog number 498.321, lot/serial #6876785

Distribution Pattern:

Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated