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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1098

28,992 detailed records are currently available in this category.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 34 consists of all product under product code: JWH and same recall — FDA Z-1132-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 59 consists of all product under product code: JWH and same recall — FDA Z-1157-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 10consists of all product under product code HWC, and same recall — FDA Z-1108-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 65 consists of all product under product code: KTT and same recall — FDA Z-1163-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 14 consists of all product under product code HSB , and recall — FDA Z-1112-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 62 consists of all product under product code: LPH and same recall — FDA Z-1160-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 19 consists of all product code: JDI and same usage: Item recall — FDA Z-1117-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 35 consists of all product under product code: JWH and same recall — FDA Z-1133-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Collagen Matrix ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in recall — FDA Z-1173-2016

The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.

Class IIIFDA: TerminatedCollagen Matrix Inc.

Medical DeviceMar 23, 2016

Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as recall — FDA Z-1177-2016

The firm discovered that the incorrect lot number was engraved on the product.

Class IIIFDA: TerminatedVolk Optical Inc.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 67 consists of all product under product code: JDI and same recall — FDA Z-1165-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Stryker Medical Division of Stryker Transport Stretcher, and Head and Neck Surgery Stretcher recall — FDA Z-1185-2016

The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear…

Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 54 consists of all product under product code: JWH and same recall — FDA Z-1152-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 1 consists of all product under , product code: JWH and recall — FDA Z-1099-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Deerfield Imaging Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and recall — FDA Z-1098-2016

Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

Class IIFDA: TerminatedDeerfield Imaging

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 64 consists of all product under product code: JDI and same recall — FDA Z-1162-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 37 consists of all product under product code: HSB and same recall — FDA Z-1135-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 27 consists of all product under product code: HSB and same recall — FDA Z-1125-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 7 consists of all products under product code HWC, and same recall — FDA Z-1105-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 8 consists of all products under product code HWC, and same recall — FDA Z-1106-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 3 consists of all products under product code JDI, and same recall — FDA Z-1101-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 15 consists of all product code JDI , and same usage: Item recall — FDA Z-1113-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 56 consists of all product under product code: HWC and same recall — FDA Z-1154-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 42 consists of all product under product code: HSB and same recall — FDA Z-1140-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.