Stryker Small Joint CORE Shaver

Technical Specs

Function

Shaver

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Operating rooms
• Procedure rooms
• Interventional suites

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Expired product distributed

• RECALL

  Product was distributed without receiving regulatory clearance.

• RECALL

  The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.

• RECALL

  Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.

• RECALL

  The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

• RECALL

  The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.

• RECALL

  Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.

• RECALL

  Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

• RECALL

  Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.

• RECALL

  Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

• RECALL

  Potential for the device cannula to overthrow past the intended length.

• RECALL

  The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

• RECALL

  STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

• RECALL

  Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.

• RECALL

  Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

• RECALL

  Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.

• RECALL

  Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.

• RECALL

  Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024" (0.6mm).

• RECALL

  Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.

• RECALL

  Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.

• RECALL

  Lack of assurance of sterility.

• RECALL

  Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.

• RECALL

  Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.