SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed recall
SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is…
Why was SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed recalled?
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 157215121 and Lot codes: 105800, 132795, 134667, AB8D51000, AB8D5A, AB8HE1000, AB8HE1A, AE3L11000, AF1EP1000, AF1EP1A, AF7KK1000, AV7JW1000, AW8F21000, AW8F2A000, BR4J81000, C15AN1000, C34B61000, C61CA1000, C77A81000, CE6FF1000, CE6FK1000, CG5B41000, CG5B41A, CK6BN1000, CK6BP1000, CK6BPA000, D32J41000, D46LD1000, D58EW1000, D74FB1000, DD3BP1000, DG1N71000, DH9JV1000, DH9JVA000, DW2A11000, E1RHD1000, E3SDC1000, E45LR1, E51E11, EB4MY1000, ED1DF1000, EH6B31000, ET4FG1000, EW7CD1000, FD4SW1, FJ9L71, and FK9D11.
- Product
- SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is…
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 1732 total all product codes
- Distribution
- Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
- Recall date
- December 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)