Recall Z-0150-2012 ยท LXH Orthopedic Manual Surgical Instrument
Encore Medical, Lp
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 pi
| Date | Nov 2, 2011 (initiated Sep 28, 2011) |
| Status | Terminated |
| Reason | 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 | 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) |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.