510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0465-2022Class II

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

Technomed Europe / initiated 2021-12-08 / Terminated / root cause: design
FDA source (opens on fda.gov)

Technomed Europe began a recall of Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001 on . FDA classified it as Class II and gives the reason as "There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0465-2022
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Technomed Europe
Product
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Product code
GXZ Electrode, Needle
Reason for recall
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
117,672 devices
Distribution
US Nationwide distribution in the states of California, Florida, and Ohio.
Product codes and lots
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)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0465-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0465-2022Class IITerminatedVoluntary: Firm initiated