Agency classClass IIOur severity:High FDA (Devices)·Z-0092-2014·Announced 2013-11-06

Stryker TPS Micro Driver Recalled for Silicone Potting Defect

Stryker is recalling 67 TPS Micro Drivers because silicone potting failed to cure properly, which could cause material leakage or electrical malfunction.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could cause electrical malfunction or material leakage, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 67 units of the REF 5100-088 TPS Micro Driver. This device is a medical instrument used in the Stryker Total Performance System for cutting, drilling, and other bone-related procedures in ENT, dental, orthopedic, and other surgical applications.

The recall was initiated because the silicone potting material, which is used to insulate, stabilize, and provide a moisture barrier to the device's main Printed Circuit Board Assembly (PCBA), failed to properly cure after the prescribed process. Inadequate curing could potentially allow the material to leak to the outside of the handpiece or cause an electrical malfunction.

The affected units were distributed worldwide, including in the United States, Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and the United Kingdom. Users should stop using the affected devices and contact Stryker for further instructions.

The recalled product

Product: REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the…
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Surgical Instruments
Hazard: electrical-malfunction
material-leakage
Affected units: 67

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

10933
11433
11483
20553
30163
31553
40713
40833
41113
50463
60133
60423
90383
110093
110193
1030133
1030403
1040413
2010013
2010123

Distribution

Distributed nationwide across the United States.

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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