Compress® Device 178711Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304430792), received between Mar 22, 2019 and Jun 11, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K041352, K043547, K112905); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE COMPRESS SEGMENT TAPER SEPARATING. IT WAS NOTED THAT THE TECHNIQUE SAYS SCREWS ARE OPTIONAL. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 22183562 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND THREE MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. ABNORMAL ROTATION OF THE FEMUR (EXTERNAL ROTATION AND NOT RETURN) OCCURRED WHEN THE PATIENT FELL. THE CAUSE OF THE PATIENT'S FALL IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21901699 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FLEXION CONTRACTURE AND STIFFNESS APPROXIMATELY TWENTY-TWO (22) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Contracture; Loss of Range of Motion

  MAUDE report 21036139 ↗
• InjuryApr 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO AN UNKNOWN FAILURE OF THE COMPRESS PROSTHESIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19098058 ↗
• InjuryJun 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE WHERE THEY IMPLANTED AN IMPLANT WITHOUT THE SCREW. POSTOPERATIVE X-RAYS TAKEN APPROXIMATELY 6 WEEKS LATER SHOWED THAT THE IMPLANTS HAD DISASSEMBLED AND THE PATIENT UNDERWENT A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 14574984 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Failure of Implant

  MAUDE report 12094358 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 11598532 ↗
• InjuryMar 22, 2019Fracture; Fracture

  IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS IMPLANT FRACTURE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: No Information

  MAUDE report 8443238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041352, K043547, K112905. One submission often covers many models, so check the product and lot details in each record.

• Z-0519-2020 · Aug 21, 2019 · Terminated
  Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 17837
• Z-0642-2019 · Oct 12, 2018 · Terminated
  Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Devi
• Z-1529-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic manual surgical instr
• Z-1530-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124. A non-powered, orthopedic manual surgic
• Z-1531-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical
• Z-1526-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086. A non-powered, orthopedic manual surgical instru
• Z-1528-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical inst
• Z-1527-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087. A non-powered, orthopedic manual surgical instrum