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U.S. Department of Health and Human Services

Class 2 Device Recall 8.0 mm Flexible Shaft Reamer

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  Class 2 Device Recall 8.0 mm Flexible Shaft Reamer see related information
Date Initiated by Firm May 02, 2016
Date Posted June 06, 2016
Recall Status1 Terminated 3 on December 13, 2016
Recall Number Z-1912-2016
Recall Event ID 74080
Product Classification Reamer - Product Code HTO
Product DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Code Information Catalog ID # 351.43 Lot numbers: XXX5071, 3945479, 4738380, XXX5072, 3997000, 4816738, XXX5073, 3996999, 4816739, A3CN449, 3997338, 4441056, 3007721, 4326050, 5407442, 3148892, 4307973, 5582819, 3175916, 4387338, 5722664, 3175202, 4441055, 5813837, 3175201, 4441079, 5786778, 3921562, 4559672, 5800844, 3928332, 4561383, 5903413, 3935789, 4619549, 5910995.
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Ms. Anne Brisson
610-719-5443
Manufacturer Reason
for Recall		 Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
FDA Determined
Cause 2		 Process design
Action Depuy Synthes sent an Urgent Notice: Medical Device Recall letter on 05/02/2016 to all affected consignees. Consignees were instructed to do the following: review your inventory immediately to see if any of the affected products were being stored, and call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement order, to complete the Verification Section (page 3) and return with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
Quantity in Commerce 244 units
Distribution US nationwide distribution.
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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