Z-1643-2011

AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy...

Name: Z-1643-2011 AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy...
Creator: Depuy Orthopaedics, Inc.
Published: 2011-01-12
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2011-01-12 / Terminated

FDA source

Depuy Orthopaedics, Inc. began a recall of AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England on 2011-01-12. The reason FDA records is "The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1643-2011
Status: Terminated
Initiated: 2011-01-12
Posted: 2011-03-22
Terminated: 2012-06-27
Recalling firm: Depuy Orthopaedics Inc.
Product: AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.
FDA root cause: Other
Action: On 1/12/2011 DePuy contacted their distributors by telephone and directed the distributors to cancel all pending surgeries and discontinue use of the sets until the investigation is completed. On 1/14/2011 DePuy again contacted all distributors by telephone and directed all distributors to return the instruments to DePuy for inspection as part of the investigation.
Quantity in commerce: 296 units
Distribution: Worldwide Distribution -- US, including the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI; and country of Switzerland.
Product codes and lots: Lots: E2FGT4, E2FGS4, E28D64, E2FGR4, E2FGP4, and EL8EN4.

Product code LXH

K100238Class IIHfn 125 Degree 9-13 Mm, 180Mm, Hfn 130 Degree 9-13 Mm, Hfn Rh 125 Degree 9-13MmDePuy Orthopaedics, Inc. / cleared 2010-05-11

MDM coverage of this record lists here, newest first.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)