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3.7mm Cannulated Locking Screws and 3.7mm Cannulated… recallZ-1800-2015 · Synthes, Inc. · initiated May 13, 2015

Class II Terminated All recalls posted in June 2015

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, Inc. 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

Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

FDA root cause category: Employee error

What the company is doing

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers to advise them about the issue and associated risks. These accounts were asked to review inventory, immediately remove the affected lots that are still in the original packaging from stock, and to complete and return the response and return authorization forms. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes consultant.

Recall details

Recall number
Z-1800-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 13, 2015
Posted by the FDA
Jun 15, 2015
Recalling firm
Synthes, Inc.
Quantity
54
Product code
HWC
FDA submissions
K000684, K050683
Distribution
Nationwide Distribution

Product description

3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.

Code information (models, lots, serial numbers)

Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046

Other devices under the same FDA submission

105 devices cleared under K000684, K050683 — 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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