Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook — Class II medical device recall Z-2054-2012
Terminated recall by Synthes (USA) Products LLC, reported 2012-08-01, distributed nationwide. USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 4
| Recall number | Z-2054-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2012-05-31 |
| Classified | 2012-07-20 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12 units |
| Lot numbers | 6876785 |
| Serial numbers | 6876785 |
| Model numbers | 498.321 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2054-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.