Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Rec
Check against the official notice below — it lists the full affected range.
Synthes (USA) Products LLC is recalling the Universal Chuck, an instrument handle used with the TN-ADVANCED Tibial Nailing System. The top cap may loosen and detach if the device becomes jammed and a user attempts to manually free it. If this occurs, internal ball bearings could fall out onto the surgical field, potentially causing surgical delays or, if not recovered, adverse tissue reactions and infections. The recall affects 600 units distributed nationwide across eleven specific lot numbers.
The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Reason for recall: Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection. Distribution: US Nationwide distribution. Quantity: 600 units Lot/code info: Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301 GTIN: 10886982297372
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.