—#177062

Product

Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K131425
Affected lot / code info: Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.

Why it was recalled

Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.

Root cause (FDA determination)

Device Design

Action the firm took

The recalling firm issued a Dear Healthcare Professional letter dated 12/6/2018 via FedEx explaining the issue and requesting the consignee examine their inventory and quarantine the percutaneous pin adapter for return to the firm. Only the percutaneous pin adapter was to be returned and not the remaining items in the assembly.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Distribution was nationwide. There was government/military/foreign distribution.

Timeline

Recall initiated: 2018-12-06
Terminated: 2020-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177062. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.