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Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar recallZ-0404-2014 · Synthes (USA) Products LLC · initiated Oct 14, 2013

Class II Terminated All recalls posted in November 2013

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

Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

FDA root cause category: Labeling mix-ups

What the company is doing

Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by: Fax: 866-229-7778 Scan/email: [email protected] Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0404-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 14, 2013
Posted by the FDA
Nov 26, 2013
Recalling firm
Synthes (USA) Products LLC
Quantity
55
Product code
JDS
FDA submissions
K111667
Distribution
Nationwide Distribution

Product description

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.

Code information (models, lots, serial numbers)

part no. 03010.438S, lot 706802

Other devices under the same FDA submission

12 devices cleared under K111667 — 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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