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U.S. Department of Health and Human Services

Class 2 Device Recall Reflex Revision Screwdriver Inner Shaft

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  Class 2 Device Recall Reflex Revision Screwdriver Inner Shaft see related information
Date Initiated by Firm June 05, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on September 22, 2008
Recall Number Z-2238-2008
Recall Event ID 48699
Product Classification Orthopedic manual surgical instrument, screwdriver - Product Code HXX
Product Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile
Code Information Lot codes: 26719, 047377, 047570, 065167, 06A167, and 072689.
Recalling Firm/
Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Michelle Klein
Manufacturer Reason
for Recall
The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
FDA Determined
Cause 2
Process control
Action URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008. If you have questions, contact Michelle Klein at 201-760-8256.
Quantity in Commerce 35
Distribution The product was distributed to 13 Stryker branches/agencies.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.