| Class 2 Device Recall Orthopedic Devices | |
Date Initiated by Firm | November 02, 2015 |
Create Date | November 20, 2015 |
Recall Status1 |
Terminated 3 on July 15, 2016 |
Recall Number | Z-0323-2016 |
Recall Event ID |
72553 |
510(K)Number | K012114 K040588 K050110 K063049 K102694 K103243 |
Product Classification |
Screw, fixation, bone - Product Code HWC
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Product | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. |
Code Information |
Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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For Additional Information Contact | 610-719-6500 |
Manufacturer Reason for Recall | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System). |
FDA Determined Cause 2 | Process control |
Action | Synthes sent an "URGENT FIELD SAFETY NOTIFICATION" letter dated November 2, 2015. Customers were asked to take the following actions:
-Review the correct package insert (GP2615, attached).
-If found, discard incorrect package insert associated with the locking screw noted in the table above.
-Forward this Field Safety Notification to anyone in your facility that needs to be informed.
-If the package insert has been forwarded to another facility, contact that facility.
-Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided.
---Send a copy of the completed Verification Section by:
-Fax: 877-907-7514 or Scan/email: Synthes7766@stericycle.com
-If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification.
-Maintain a copy of this Notification. |
Quantity in Commerce | 229 |
Distribution | Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HWC
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