—#146229

Product

DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2016-05-02
Posted by FDA: 2016-06-06
Terminated: 2016-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.