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7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number… recallZ-1548-2010 · Synthes USA (HQ), Inc. · initiated Feb 25, 2010

Terminated All recalls posted in May 2010

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

potential compatibility issue

FDA root cause category: Device Design

What the company is doing

The recalling firm, Synthes, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated February 25, 2010, return receipt requested, to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately cease use of the products, examine their inventory for the part/lot combinations and remove the recalled devices from their shelves, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number and return the recalled product with the letter; however, if the customers do not have the identified product , they should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at [email protected]. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.

Recall details

Recall number
Z-1548-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 25, 2010
Posted by the FDA
May 7, 2010
Recalling firm
Synthes USA (HQ), Inc.
Quantity
1 unit
Product code
JDS
FDA submissions
K992348
Distribution
Nationwide distribution: LA, MA, ME, NC, PA and VA.

Product description

7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures.

Code information (models, lots, serial numbers)

Catalog/Part number 462.723S. Lot number 6303874 exp 12/2018

Other devices under the same FDA submission

12 devices cleared under K992348 — 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 55147).

Sources and updates

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