DePuy Orthopaedics, Inc.: RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.

Is my product affected?

RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.

• UPC 10603295156192

Check against the official notice below — it lists the full affected range.

What happened

DePuy Orthopaedics, Inc. has recalled 54 units of the RECLAIM Assembled Implant Inserter Adaptor Instrument (Catalog No. 2975-00-920, Lot No. SO2018074) used in hip implant surgery. The device may fracture during surgical use, potentially leaving plastic pieces inside the patient's body.

The affected lot was distributed worldwide in California, Ireland, and Israel. The source document does not specify what consumers or patients should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.

Details from the source

Reason for recall: This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient. Distribution: Worldwide Distribution: US (nationwide) in CA; Ireland and Israel. Quantity: 54 of Lot No: SO2018074 Lot/code info: CATALOG NO. : 2975-00-920: Barcode (GTIN): 10603295156192 Lot No. Distribution SO2018074 (Distributed) SO2018072 (Not Distributed) SO2018073 (Not Distributed) SO2018075 (Not Distributed) SO2018080 (Not Distributed)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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