Z-1912-2016Class II

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

Name: Z-1912-2016 DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Creator: Synthes (USA) Products LLC
Published: 2016-05-02
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-02 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43 on 2016-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1912-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Posted: 2016-06-06
Terminated: 2016-12-13
Recalling firm: Synthes (USA) Products LLC
Product: DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Product code: HTO Reamer
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1912-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1912-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)