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U.S. Department of Health and Human Services

Class 2 Device Recall LineSider Spinal System

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  Class 2 Device Recall LineSider Spinal System see related information
Date Initiated by Firm January 27, 2022
Date Posted December 05, 2022
Recall Status1 Open3, Classified
Recall Number Z-0418-2023
Recall Event ID 91070
510(K)Number K203367  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes:

a. 5.5mm x 35mm;

b. 5.5mm x 40mm;

c. 5.5mm x 45mm;

d. 5.5mm x 50mm;

e. 5.5mm x 55mm;

f. 6.5mm x 35mm;

g. 6.5mm x 40mm;

h. 6.5mm x 45mm;

i. 6.5mm x 50mm;

j. 6.5mm x 55mm;

k. 6.5mm x 60mm;

l. 7.5mm x 35mm;

m. 7.5mm x 40mm;

n. 7.5mm x 50mm;

o. 7.5mm x 55mm;

p. 7.5mm x 60mm;

q. 8.5mm x 35mm;

r. 8.5mm x 40mm;

s. 8.5mm x 45mm;

t. 8.5mm x 50mm;

u.8.5mm x 55mm;

v. 8.5mm x 60mm;

Used in spinal fixation surgery.
Code Information a. 5.5mm x 35mm, Part Number: LS-N6SA5535, UDI: (01)00818613027716(10)02210117, lot Number: 2210117; Part Number: LS-N6SA7545, UDI: (01)00818613027884(10)02210130, Lot Number: 2210130. b. 5.5mm x 40mm, Part Number: LS-N6SA5540, UDI: (01)00818613027723(10)02210118, Lot Number: 2210118. c. 5.5mm x 45mm, Part Number: LS-N6SA5545, UDI: (01)00818613027730(10)02210119, Lot Number: 2210119. d. 5.5mm x 50mm, Part Number: LS-N6SA5550, UDI: (01)00818613027747(10)02210120, Lot Number: 2210120. e. 5.5mm x 55mm, Part Number: LS-N6SA5555, UDI: (01)00818613027754(10)02210121, Lot Number: 2210121. f. 6.5mm x 35mm, Part Number: LS-N6SA6535, UDI: (01)00818613027792(10)02210122, Lot Number: 2210122. g. 6.5mm x 40mm, Part Number: LS-N6SA6540, UDI: (01)00818613027808(10)02210123, Lot Number: 2210123. h. 6.5mm x 45mm, Part Number: LS-N6SA6545, UDI: (01)00818613027815(10)02210124, Lot Number: 2210124. i. 6.5mm x 50mm, Part Number: LS-N6SA6550, UDI: (01)00818613027822(10)02210125, Lot Number: 2210125. j. 6.5mm x 55mm, Part Number: LS-N6SA6555, UDI: (01)00818613027839(10)02210126, Lot Number: 2210126. k. 6.5mm x 60mm, Part Number: LS-N6SA6560, UDI: (01)00818613027846(10)02210127, Lot Number: 2210127. l. 7.5mm x 35mm, Part Number: LS-N6SA7535, UDI: (01)00818613027860(10)02210128, Lot Number: 2210128. m. 7.5mm x 40mm, Part Number: LS-N6SA7540, UDI: (01)00818613027877(10)02210129, Lot Number: 2210129. n. 7.5mm x 50mm, Part Number: LS-N6SA7550, UDI: (01)00818613027891(10)02210131, Lot Number: 2210131. o. 7.5mm x 55mm, Part Number: LS-N6SA7555, UDI: (01)00818613027907(10)02210132, Lot Number: 2210132. p. 7.5mm x 60mm, Part Number: LS-N6SA7560, UDI: (01)00818613027914(10)02210133, Lot Number: 2210133. q. 8.5mm x 35mm, Part Number: LS-N6SA8535, UDI: (01)00818613027938(10)02210134, Lot Number: 2210134. r. 8.5mm x 40mm, Part Number: LS-N6SA8540, UDI: (01)00818613027945(10)02210135, Lot Number: 2210135. s. 8.5mm x 45mm, Part Number: LS-N6SA8545, UDI: (01)00818613027952(10)02210136, Lot Number: 2210136. t. 8.5mm x 50mm, Part Number: LS-N6SA8550, UDI: (01)00818613027969(10)02210137, Lot Number: 2210137. u.8.5mm x 55mm, Part Number: LS-N6SA8555, UDI: (01)00818613027976(10)02210138, Lot Number: 2210138. v. 8.5mm x 60mm, Part Number: LS-N6SA8560, UDI: (01)00818613027983(10)03210142, Lot Number: 3210142.
Recalling Firm/
Manufacturer		 Integrity Implants Inc.
354 Hiatt Drive
Palm Beach Gardens FL 33418
For Additional Information Contact Integrity Implants Customer Service
800-201-9300
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action Integrity Implants notified consignees on 01/28/2022, via emailed letter. The letter instructed consignees to quarantine affected product, complete and return the Product Tracking & Verification Form, and return affected product. On 02/05/2022 the recall was expanded, and consignees were notified via emailed letter. The listed the additional affected product and contained the same instructions to consignees.
Quantity in Commerce 1,227 screws
Distribution Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = Integrity Implants Inc.
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