Z-2127-2014Class II

Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments...

Name: Z-2127-2014 Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments...
Creator: Small Bone Innovations
Published: 2014-05-19
License: https://open.fda.gov/license/

Small Bone Innovations, Inc. / initiated 2014-05-19 / Terminated / root cause: manufacturing process

FDA source

Small Bone Innovations began a recall of Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws... on 2014-05-19. FDA classified it as Class II and gives the reason as "Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2127-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Posted: 2014-07-30
Terminated: 2014-10-08
Recalling firm: Small Bone Innovations, Inc.
Product: Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Small Bone Innovations sent an Urgent Medical Device Recall letter, dated May 19, 2014, to all affected customers. The letter that described the product problem, and the action to be taken by the customer. was sent to sales reps, stocking customers, and distributors. Customers were instructed that a copy of the IFU should be stored with each unpackaged AutoFIX 3.0/4.0mm Compression Screw Sets, Implants, or Instruments in their current inventory. Customers were instructed to return all packaged affected product which would be replaced by the firm with an updated IFU. A Federal Express return label was included to facilitate the return shipment. Customers were instructed to complete, sign, and return with the product the Return Material Authorization (RMA) document. For questions regarding this recall call 215-428-1791.
Quantity in commerce: 506
Distribution: Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2127-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2127-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-30

Product code HWC

K052576Class IISbi AutofixSmall Bone Innovations, LLC / cleared 2005-11-07

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)