Food, drugs, devices › Synthes (USA) Products LLC
Device recall: Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical s
Synthes (USA) Products LLC (West Chester, PA) initiated this device recall on 31 May 2012; FDA lists 1 product record under event 62324, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 31 Aug 2015. Initiation: voluntary: firm initiated. Synthes (USA) Products LLC has 72 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Synthes (USA) Products LLC, West Chester, PA.
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)."
Distribution
"Nationwide Distribution including GA, PA, SC, TX, and UT and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2054-2012 | 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… | 12 units | Class II | Terminated | 1 Aug 2012 |
Context
Other enforcement events for Synthes (USA) Products LLC
All 72 events for Synthes (USA) Products LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including GA, PA, SC, TX, and UT and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Aug 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.