Compress® Device 178410Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K031804, K043547); 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.

Recalls naming this device

Oct 9, 2023Open, Classified
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Z-0375-2024 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031804, K043547. One submission often covers many models, so check the product and lot details in each record.

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-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-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-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-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

Device details

UDI-DI	`00880304259782`
Brand	Compress® Device
Model	178410
Company	Biomet Orthopedics, LLC
Product code	JDI · Prosthesis, hip, semi-constrained, metal/polymer, cemented
Class	Class 2
FDA submission	K031804, K043547
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 25, 2026

Device type (GMDN): Orthopaedic bone pin, non-bioabsorbable

A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

NA 1365-51-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
753 reports
NA 1365-50-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
412 reports
ARTICUL/EZE 1365-21-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
1 recall280 reports
ARTICUL/EZE 1365-11-000
Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented
1 death262 reports
LFIT 6260-9-236
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
256 reports
PINNACLE GRIPTION 1217-32-052
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
2 deaths239 reports
ELEOS™ 25002111E
Onkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented
3 deaths230 reports
Novation 130-36-52
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
2 recalls124 reports

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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