NA 208.438Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982149435), received between Jan 9, 2018 and Feb 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K021932, K161616); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2021. ONE (1) 6.5MM CANNULATED SCREW 32MM THREAD 80MM AND ONE (1) WASHER 13.0MM WERE EXPLANTED FROM THE PELVIS DUE TO PAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATE: (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 6.5MM CANNULATED SCREW 32MM THREAD 80MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11330322 ↗
• InjuryJan 9, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION OF HIP PINNING WAS CONDUCTED ON (B)(6) 2017 AFTER THE PATIENT WAS IMPLANTED ON (B)(6) 2017. THE PATIENT WAS REVISED TO A 4.5MM PROXIMAL FEMUR PLATE. FIVE 6.5MM PARTIALLY (32MM) THREADED CANNULATED SCREWS (80, 90, 95, 100, 110MM) AND FOUR WASHERS WERE REMOVED FROM THE PATIENT; ONE WASHER WAS LEFT IN PATIENT. REMOVAL OF HARDWARE WAS QUICK AND EASY. THE SCREWS WERE REPLACED WITH A PROXIMAL FEMUR PLATE AS THE SCREW FIXATION FAILED. THE SURGEON WAS UNABLE TO RETRIEVE THE WASHER IMPLANTED IN THE PATIENT BECAUSE SHE PLATED OVER THE SCREW. ORIGINALLY, SHE WAS GOING TO LEAVE IT IN, BUT THEN DECIDED TO TRY AND TAKE OUT THE SCREW AND THE WASHER AFTER PLATING. THE SCREW WAS ABLE TO BE RETRIEVED, BUT NOT THE WASHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTEDLY STABLE. CONCOMITANT DEVICES: WASHER (PART 219.99, LOT UNKNOWN, QUANTITY 5) THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7175587 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021932, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2016 · Feb 16, 2016 · Terminated
  4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large b
• Z-2152-2016 · Feb 16, 2016 · Terminated
  6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragment
• Z-2156-2016 · Feb 16, 2016 · Terminated
  4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, s
• Z-2154-2016 · Feb 16, 2016 · Terminated
  7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bo
• Z-2155-2016 · Feb 16, 2016 · Terminated
  4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone
• Z-2158-2016 · Feb 16, 2016 · Terminated
  3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bo
• Z-2153-2016 · Feb 16, 2016 · Terminated
  6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragment