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Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm… recallZ-0681-2017 · Synthes (USA) Products LLC · initiated Nov 1, 2016

Class II Terminated All recalls posted in December 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

FDA root cause category: Under Investigation by firm

What the company is doing

DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units.

Recall details

Recall number
Z-0681-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 1, 2016
Posted by the FDA
Dec 1, 2016
Recalling firm
Synthes (USA) Products LLC
Quantity
84 units
Product code
HWE
FDA submissions
K043310
Distribution
Distributed Nationwide

Product description

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Code information (models, lots, serial numbers)

Model/Catalog # 316.15 Lot/Serial Number U172728

Other devices under the same FDA submission

66 devices cleared under K043310 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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