Universal Spinal System Lamina Hooks Synthes Medium TI recall
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices…
Why was Universal Spinal System Lamina Hooks Synthes Medium TI recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number 498.321, lot/serial #6876785
- Product
- Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 12 units
- Distribution
- Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
- Recall date
- August 1, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)