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U.S. Department of Health and Human Services

Class 2 Device Recall Trial Spacer

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  Class 2 Device Recall Trial Spacer see related information
Date Initiated by Firm September 05, 2019
Create Date November 08, 2019
Recall Status1 Terminated 3 on June 23, 2020
Recall Number Z-0349-2020
Recall Event ID 83991
Product Classification unknown device name - Product Code N/A
Product MODIFIED INSTRUMENTS:
Trial Spacer 7mm with T-Handle
Trial Spacer 8mm with T-Handle
Trial Spacer 9mm with T-Handle
Trial Spacer 10mm with T-Handle
Trial Spacer 11mm with T-Handle
Trial Spacer 12mm with T-Handle
Trial Spacer 13mm with T-Handle
Trial Spacer 15mm with T-Handle
Trial Spacer 17mm with T-Handle
Code Information Unknown
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall		 Modified outside of approved manufacturing process
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DePuy Synthes notified account by letter dated 10/4/19 stating reason for recall, health risk and action take: The modified instruments were removed from your facility on September 5, 2019. Please complete the Business Reply Form acknowledging that the modified instruments are not in the possession of your facility. Return the completed Business Reply Form to you sales consultant or email to DPYUS-SpineFieldActions@its.jnj.com within five (5) business days of this notice. Questions, or become aware of an adverse event associated with the subject devices, please call our Recall Hotline at 610-719-5450 (8 am  5 pm, Eastern time, M-F) or contact your DePuy Synthes Sales Consultant.
Quantity in Commerce 9 units
Distribution AR
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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