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2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess… recallZ-0167-2016 · Synthes (USA) Products LLC · initiated Oct 6, 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

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

FDA root cause category: Packaging

What the company is doing

Synthes sent an URGENT NOTICE: MEDICAL DEVICE NOTIFICATION UPDATED INFORMATION: CORRECTED LOT NUMBER SS 2.7mm Locking Screw, self-tapping letter dated January 13, 2014, to the affected customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 3 of this letter) with the product to: Credit/Returns, Synthes. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the documents to Synthes by: Fax: 1-866-792-5446 or Scan/email: [email protected] If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. For further questions please call 610-719-6500.

Recall details

Recall number
Z-0167-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 6, 2015
Posted by the FDA
Oct 30, 2015
Recalling firm
Synthes (USA) Products LLC
Quantity
98
Product code
HRS
FDA submissions
K063049
Distribution
US Distribution to the state of : TN

Product description

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

Code information (models, lots, serial numbers)

Part Number 202.212 Lot Number 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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