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U.S. Department of Health and Human Services

Class 2 Device Recall LITe DECOMPRESSION

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 Class 2 Device Recall LITe DECOMPRESSIONsee related information
Date Initiated by FirmNovember 01, 2023
Date PostedDecember 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0610-2024
Recall Event ID 93573
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductLITe Decompression Snake Arm, REF 48080230
Code Information UDI-DI (GTIN): 07613327263909, lot # 227764.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact
201-825-4900
Manufacturer Reason
for Recall		Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionStryker issued Urgent Medical Device Correction on 11/20/2023 notifying customers of removal of lot 227764 of the LITe Decompression Tube Snake Arm, catalog number 48080230. A portion of one lot of the LITe Decompression Tube Snake Arm was manufactured with the incorrect clamp component. As a result, the affected Snake Arms cannot attach to the arm post shaft. Customers are to review inventory and remove units from points of use for return to Stryker, share this information with appropriate personnel and return the Business Reply form to Spine-RegulatoryActions@Stryker.com. If you have any questions or concerns, please contact Regulatory Compliance at (201) 749-8090.
Quantity in Commerce9
DistributionUS: MD, MI, NM, TX & OUS: Canada & France.
Total Product Life CycleTPLC 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.
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