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Synthes Screw Inserter recallZ-0126-2016 · Synthes (USA) Products LLC · initiated Sep 21, 2015

Class II Terminated All recalls posted in October 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 (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

Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

FDA root cause category: Device Design

What the company is doing

DePuy Synthes sent an urgent notice of medical device recall letter dated September 21, 2015, to all affected customers to notify them about the issue, the potential risks, and to provide instructions for return of the completed response form and affected devices. Customers with questions were instructed to call 610-719-5450.

Recall details

Recall number
Z-0126-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 21, 2015
Posted by the FDA
Oct 15, 2015
Recalling firm
Synthes (USA) Products LLC
Quantity
793
Product code
HSB
FDA submissions
K131548
Distribution
US Nationwide Distribution

Product description

Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.

Code information (models, lots, serial numbers)

Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407

Other devices under the same FDA submission

172 devices cleared under K131548 — 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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