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2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive… recallZ-0380-2014 · Synthes USA HQ, Inc. · initiated Jul 31, 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 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

Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

FDA root cause category: Labeling mix-ups

What the company is doing

Synthes sent an URGENT NOTICE: MEDICAL DEVICE RECALL letter dated July 31, 2013, to all affected customer. 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 Nuber, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Fax the documents to Synthes at 1-866-792-6446 or email to [email protected]. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0380-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 31, 2013
Posted by the FDA
Nov 22, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
98
Product code
HRS
FDA submissions
K063049
Distribution
Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.

Product description

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Code information (models, lots, serial numbers)

Lot 3420620

Other devices under the same FDA submission

107 devices cleared under K063049 — 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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