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Technomed Europe recallZ-0465-2022 · Technomed Europe · initiated Dec 8, 2021

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 Technomed Europe 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

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

FDA root cause category: Device Design

What the company is doing

The firm distributed an Urgent Medical Device Recall notice dated 12/07/2021 to customers in the United States via email on 12/08/2021. In this notice the firm identifies affected product as being recalled due to the high risk of the needle electrode and lead wire coming loose from the hub, resulting in potential medical intervention to remove the inserted needle electrode, including removal using forceps or incision. The recalling firm requested that customers notify any recipients of recalled product down the distribution chain by forwarding a copy of the notice, that the customer be aware that the firm will schedule a telephone call to initiate the replacement of affected product, and that only distributors return the provided Acknowledgement Form following the scheduled phone call to [email protected]. Customers are asked to ascertain the amount of affected product on hand to be returned with their lot numbers for the scheduled call. Customers with any questions are to contact the recalling firm at [email protected] or by phone at +31 43 608 48 48.

Recall details

Recall number
Z-0465-2022
Status
Terminated
Initiated by the company
Dec 8, 2021
Recalling firm
Technomed Europe
Quantity
117,672 devices
Product code
GXZ
FDA submissions
K130136
Distribution
US Nationwide distribution in the states of California, Florida, and Ohio.

Product description

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

Read as "Lot Number (UDI-DI, Product Number)": 048565 (08718375861707, TE/S50715-004), 048670 (08718375867549, TE/S50715-001-C), 048949 (08718375867549, TE/S50715-001-C), 049013 (08718375865439, SO-ELCS20), 049013 (08718375865439, SO-ELCS20), 049014 (08718375867549, TE/S50715-001-C), 049014 (08718375867549, TE/S50715-001-C), 049165 (08718375865439, SO-ELCS20), 049166 (08718375867853, TE/S50725-001-C), 049166 (08718375867853, TE/S50725-001-C), 049166 (08718375867853, TE/S50725-001-C), 049166 (08718375867853, TE/S50725-001-C), 049167 (08718375867549, TE/S50715-001-C), 049167 (08718375867549, TE/S50715-001-C), 049167 (08718375867549, TE/S50715-001-C), 049167 (08718375867549, TE/S50715-001-C), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049191 (08718375861684, TE/S50715-002), 049191 (08718375861684, TE/S50715-002), 049191 (08718375861684, TE/S50715-002), 049191 (08718375861684, TE/S50715-002), 049192 (08718375861547, TE/S50715-001), 049192 (08718375861547, TE/S50715-001), 049192 (08718375861547, TE/S50715-001), 049192 (08718375861547, TE/S50715-001), 049193 (08718375866863, TE/S50725-002), 049193 (08718375866863, TE/S50725-002), 049193 (08718375866863, TE/S50725-002), 049193 (08718375866863, TE/S50725-002), 049328 (08718375861707, TE/S50715-004), 049328 (08718375861707, TE/S50715-004), 049328 (08718375861707, TE/S50715-004), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049443 (08718375867549, TE/S50715-001-C), 049443 (08718375867549, TE/S50715-001-C), 049502 (08718375867549, TE/S50715-001-C), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049549 (08718375867549, TE/S50715-001-C), 049552 (08718375867549, TE/S50715-001-C), 049552 (08718375867549, TE/S50715-001-C), 049603 (08718375861691, TE/S50715-003), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049710 (08718375867549, TE/S50715-001-C), 049710 (08718375867549, TE/S50715-001-C), 049735 (08718375861707, TE/S50715-004), 049735 (08718375861707, TE/S50715-004), 049736 (08718375867549, TE/S50715-001-C), 049802 (08718375867549, TE/S50715-001-C), 049847 (08718375865439, SO-ELCS20), 049847 (08718375865439, SO-ELCS20), 049855 (08718375861691, TE/S50715-003), 049855 (08718375861691, TE/S50715-003), 049855 (08718375861691, TE/S50715-003), 049858 (08718375861707, TE/S50715-004), 049858 (08718375861707, TE/S50715-004), 049861 (08718375867549, TE/S50715-001-C), 049871 (08718375866863, TE/S50725-002), 049878 (08718375867549, TE/S50715-001-C), 049924 (08718375861707, TE/S50715-004), 049925 (08718375861684, TE/S50715-002), 049925 (08718375861684, TE/S50715-002), 049932 (08718375861707, TE/S50715-004), 049932 (08718375861707, TE/S50715-004), 049932 (08718375861707, TE/S50715-004), 049955 (08718375866863, TE/S50725-002), 049955 (08718375866863, TE/S50725-002), 049969 (08718375867549, TE/S50715-001-C), 049970 (08718375867549, TE/S50715-001-C), 049982 (08718375861547, TE/S50715-001), 049982 (08718375861547, TE/S50715-001), 049989 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 050077 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050136 (08718375867549, TE/S50715-001-C), 050136 (08718375867549, TE/S50715-001-C), 050240 (08718375861707, TE/S50715-004), 050240 (08718375861707, TE/S50715-004), 050240 (08718375861707, TE/S50715-004), 050240 (08718375861707, TE/S50715-004), 050395 (08718375866863, TE/S50725-002), 050395 (08718375866863, TE/S50725-002), 050715 (N/A, NS/DC990106.041-001)

Devices named in this recall

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

Product lines

Sources and updates

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