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4.5mm TI Multiloc Screw Length 28MM-Sterile recallZ-2060-2012 · Synthes USA HQ, Inc. · initiated May 22, 2012

Class II Terminated All recalls posted in July 2012

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 HQ, 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

Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

FDA root cause category: Error in labeling

What the company is doing

Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated May 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this recall.

Recall details

Recall number
Z-2060-2012
Recall class
Class II
Status
Terminated
Initiated by the company
May 22, 2012
Posted by the FDA
Jul 23, 2012
Recalling firm
Synthes USA HQ, Inc.
Quantity
20
Product code
HSB
FDA submissions
K103002
Distribution
Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.

Product description

4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).

Code information (models, lots, serial numbers)

Lot #2721745 Expiration 4/29/2012 REF 04.019.028S

Other devices under the same FDA submission

69 devices cleared under K103002 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 62307).

Sources and updates

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