FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA
- Recall number
- Z-1236-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA
- Status
- Terminated
- Initiated
- 2007-11-15
- Posted
- 2008-06-26
- Terminated
- 2010-01-25
- Reason
- Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.
- Root cause
- Process control
- Action
- On 11/28/2007, Stryker Orthopaedics sent, via FedEx, Urgent Product Recall notification letters to distributors, hospitals, surgeons and hospitals' Chiefs of Orthopaedics informing them of the firm's voluntary recall of the affected product. They were instructed to discontinue use of the product and to have the units returned to the firm. Distributors were further instructed to notify their customers using the sub-recall letter provided by the firm. The letter to surgeons also informed them to monitor their patients who had received an implant of the product.
- Quantity
- 915 units
- Distribution
- Nationwide - USA
- Lot, serial or model codes
- All Lot Codes for the following: Catalog # 5351-4307, 7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm; 5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316, 16mm; and 5351-4317, 17mm.
- 510(k) numbers
- ["K061677"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28