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DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2… recallZ-0574-2021 · Synthes (USA) Products LLC · initiated Nov 19, 2020

Terminated

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

RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

FDA root cause category: Use error

What the company is doing

DePuy Synthes issued voluntary device correction letter on 11/19/202 via 2-day by Fed Ex, stating reason for recall, health risk and action to take: This safety notification is advising physicians of the following supplemental information regarding the surgical approach of standard IM nail reaming as referred to in the surgical technique guide. Open the medullary canal and conduct reaming by following AO reaming techniques for IM nailing and maintain a guide wire entry angle of less than 10 from the axis of the canal. CAUTION: If the guide wire entry angle is greater than 10 from the axis of the canal, there is a risk that bowing of the reaming rod will result in: o Eccentric reaming of the far cortex o Damage to the reamer head connection, resulting in metal fragments in the canal NOTE: " For an antegrade femoral approach, if possible, adduct the limb/hip to facilitate access to entry point. For greater trochanter entry point, target >2cm distal to the lesser trochanter1. " For an antegrade tibial approach, the knee will need to be flexed to 90-110 for entry site access. Insert the guide wire aiming down the tibial crest, and thus the center of the medullary canal Please take the following actions: " Forward this notice to anyone in your facility that needs to be informed. " If any of the subject product has been forwarded to another facility, contact that facility. " Keep a copy of this notice with the subject product. " Identify and discard any current Printed Surgical Technique. " To get the updated version visit our website: https://www.jnjmedicaldevices.com/en-US/product/ria-2-system-reamer-irrigator-aspirator " Review, complete, sign, and return the attached reply form on page 4 of this letter to your local sales organization in accordance with the directions on the form within 5-business days of receipt of this notification. " Should you have any inquiries please do not hesitate to contact your sales consultant " This letter

Recall details

Recall number
Z-0574-2021
Status
Terminated
Initiated by the company
Nov 19, 2020
Recalling firm
Synthes (USA) Products LLC
Quantity
1231US; 422 OUS
Product code
HTO
FDA submissions
K042899, K111437, K013527, K993335
Distribution
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,

Product description

DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S

Code information (models, lots, serial numbers)

All Lots UDI: 10886982273970

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

13 devices cleared under K042899, K111437, K013527, K993335 are not named by identifier in this recall. 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 86713).

Sources and updates

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