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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/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Michelle Klein
201-760-8256
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.
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