Compress® Device 178414Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Data updated Oct 13, 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. How this data works · Data updated Oct 13, 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-0377-2024 · Root cause: Device Design · 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-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
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-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-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

Device details

UDI-DI	`00880304259829`
Brand	Compress® Device
Model	178414
Company	Biomet Orthopedics, LLC
Product code	LZO · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
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/ceramic/polymer, cemented or non-porous, uncemented devices

BIOLOX DELTA 1365-32-310
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
551 reports
PINNACLE ALTRX 1221-36-052
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
481 reports
BIOLOX DELTA 1365-32-320
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
1 death314 reports
BIOLOX DELTA 1365-36-720
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
1 death189 reports
DJO SURGICAL 400-03-362
Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
187 reports
Anthology 71365705
Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
176 reports
BIOLOX DELTA 1365-40-710
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
170 reports
PINNACLE GRIPTION 1217-32-054
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
169 reports

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented 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 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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