Reported Dec 14, 2022 · Terminated
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw…
Integrity Implants Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integrity Implants Inc. · 354 Hiatt Drive · Palm Beach Gardens, FL · 33418
Is this the product you have?
22 of 22 products
| # | Product as published |
|---|---|
| 1 | 5.5mm x 35mm |
| 2 | 5.5mm x 40mm |
| 3 | 5.5mm x 45mm |
| 4 | 5.5mm x 50mm |
| 5 | 5.5mm x 55mm |
| 6 | 6.5mm x 35mm |
| 7 | 6.5mm x 40mm |
| 8 | 6.5mm x 45mm |
| 9 | 6.5mm x 50mm |
| 10 | 6.5mm x 55mm |
| 11 | 6.5mm x 60mm |
| 12 | 7.5mm x 35mm |
| 13 | 7.5mm x 40mm |
| 14 | 7.5mm x 45mm |
| 15 | 7.5mm x 50mm |
| 16 | 7.5mm x 55mm |
| 17 | 7.5mm x 60mm |
| 18 | 8.5mm x 35mm |
| 19 | 8.5mm x 40mm |
| 20 | 8.5mm x 45mm |
- Lot codes and dates
22 of 22 products
Products covered by this recall Model / number Barcodes Product as published LS-N6SG5535008186130225685.5mm x 35mm, , UDI: (01)00818613022568(10)02210139, lot Number: 2210139. LS-N6SG5540008186130225755.5mm x 40mm, , UDI: (01)00818613022575(10)02210140, Lot Number: 2210140. LS-N6SG5545008186130225825.5mm x 45mm, , UDI: ((01)00818613022582(10)02210141, Lot Number: 2210141. LS-N6SG5550008186130225995.5mm x 50mm, , UDI: (01)00818613022599(10)02210142, Lot Number: 2210142. LS-N6SG5555008186130226055.5mm x 55mm, , UDI: (01)00818613022605(10)02210143, Lot Number: 2210143. LS-N6SG6535008186130226436.5mm x 35mm, , UDI: (01)00818613022643(10)02210144, Lot Number: 2210144. LS-N6SG6540008186130226506.5mm x 40mm, , UDI: (01)00818613022650(10)02210145, Lot Number: 2210145. LS-N6SG654500818613022667008186130226676.5mm x 45mm, , UDI: (01)00818613022667(10)02210146, Lot Number: 2210146, UDI: (01)00818613022667(10)02210146-1, Lot Number: 02210146-1. LS-N6SG6550008186130226746.5mm x 50mm, , UDI: (01)00818613022674(10)02210147, Lot Number: 2210147. LS-N6SG6555008186130226816.5mm x 55mm, , UDI: (01)00818613022681(10)02210148, Lot Number: 2210148. LS-N6SG6560008186130226986.5mm x 60mm, , UDI: (01)00818613022698(10)02210149, Lot Number: 2210149. LS-N6SG7535008186130227117.5mm x 35mm, , UDI: (01)00818613022711(10)02210150, Lot Number: 2210150. LS-N6SG7540008186130227357.5mm x 40mm, , UDI: (01)00818613022735(10)02210152, Lot Number: 2210151. LS-N6SG7545008186130278917.5mm x 45mm, , UDI: (01)00818613027891(10)02210131, Lot Number: 2210152. LS-N6SG7550008186130227427.5mm x 50mm, , UDI: (01)00818613022742(10)02210153, Lot Number: 2210153. LS-N6SG7555008186130227597.5mm x 55mm, , UDI: (01)00818613022759(10)02210154, Lot Number: 2210154. LS-N6SG7560008186130227667.5mm x 60mm, , UDI: (01)00818613022766(10)02210155, Lot Number: 2210155. LS-N6SG8535008186130227808.5mm x 35mm, , UDI: (01)00818613022780(10)02210156, Lot Number: 2210156. LS-N6SG8540008186130227978.5mm x 40mm, , UDI: (01)00818613022797(10)02210157, Lot Number: 2210157. LS-N6SG8545008186130228038.5mm x 45mm, , UDI: (01)00818613022803(10)02210158, Lot Number: 2210158. - Amount recalled
- 1,702 screws
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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