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U.S. Department of Health and Human Services

Class 2 Device Recall Graphic Case 6.5mm & 7.3mm Cannulated Screw Sets

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  Class 2 Device Recall Graphic Case 6.5mm & 7.3mm Cannulated Screw Sets see related information
Date Initiated by Firm March 05, 2018
Create Date June 15, 2018
Recall Status1 Terminated 3 on February 28, 2020
Recall Number Z-2245-2018
Recall Event ID 79754
Product Classification Tray, surgical, instrument - Product Code FSM
Product Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
Code Information FL00860
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Ms. Jody Cadd
610-314-2106
Manufacturer Reason
for Recall
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
FDA Determined
Cause 2
Process control
Action On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange return. Customers with questions were advised to call 610-719-5450, 8AM-5PM (EST), Monday through Friday, or contact their DePuy Synthes sales consultant.
Quantity in Commerce 7
Distribution Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
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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