Z-0150-2012

RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore...

Name: Z-0150-2012 RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore...
Creator: Encore Medical, Lp
Published: 2011-09-28
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2011-09-28 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758... on 2011-09-28. The reason FDA records is "DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0150-2012
Status: Terminated
Initiated: 2011-09-28
Posted: 2011-11-02
Terminated: 2013-03-29
Recalling firm: Encore Medical, LP
Product: RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU.
Root cause tag: design
FDA root cause: Device Design
Action: DJO Surgical sent an URGENT FIELD SAFETY NOTICE letter dated September 28, 2011, to all affected customers. The letter identified the product. the problem, and the action to be taken by the customer. Customers were instructed to return the RSP Humeral Socket Reamers and RSP Baseplate Rim Planers. The RSP Humeral Socket Reamers will be reworked and returned to the customer. The Baseplast Rim Planer will be replaced when a suitable design is available. During the interim until instruments are returned, the use of FMP acetabular reamers size 42mm, 43mm, 45mm (DJO PIN 803-05-226, 227, 200) for the humeral preparation was validated to be effective to prepare the humerus for the implant. Customers were instructed to immediately notify the hospitals and surgeons using these devices and document it on the Field Safety Notice Response Form. For questions regarding this recall call 512-832-9500.
Quantity in commerce: 399 Reamers
Distribution: Worldwide Distribution - USA including AR, AZ, CA, CO, FL,GA, ID, IN, IL, LA, MA, MD, ME, MI, MO, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, and WI and Internationally toGermany, South America, Italy, Saudi Arabia, United Kingdom, and Canada.
Product codes and lots: All lots are being recalled. DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)